Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).
University of Newcastle upon Tyne · Academic
In term In term in the September 2026 edition: the latest version runs to 14 May 2027.
- Reference
- DARS-NIC-361864-N8P1S
- Current version
- v2.4
- Term of current version
- 15 May 2026 to 14 May 2027
- Start date
- 15 May 2023
- Data controller
- Joint Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 30
Data controllers
Why the data was released
Objective for processing
Heart surgery to repair one of the valves in the heart (the mitral valve) is commonly performed in the NHS. Patients needing this operation sometimes suffer symptoms of shortness of breath (especially when exercising), tiredness, and swollen ankles, caused by the valve becoming leaky (mitral regurgitation), while other patients suffer very few symptoms. Both sets of patients are often of working age, so time away from their place of work can be difficult for a number of reasons. It is essential to make sure that the operations offered within the NHS are best for patients. To repair the valve, the operation usually involves cutting the breastbone completely (from the collar bone to the bottom of the breastbone); a sternotomy. However, an operation has been developed which means that the valve can be repaired using a much smaller cut on the side of the chest; a mini thoracotomy. Mitral valve repair (MVr) surgery for mitral valve regurgitation was being performed more frequently with patient numbers increasing by a third between 2003 and 2012. In recent years, figures of surgeries have remained at a similar level and whilst have shown declines at times when COVID-19 admissions have peaked, surgery figures have shown further sharp increases once COVID-19 admissions decreased and show a continued need with the patient population for treatment. This rise is expected to continue in an ageing population, alongside a recognition in the international guidance that asymptomatic patients may also benefit from early surgery. Together this presents a growing patient need to ensure treatment is considered and delivered as effectively as possible.
The lawful basis for carrying out this study under UK GDPR is:
- Article 6 (1)(e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller͟”.
- Article 9 (2)(j) – “processing is necessary for achieving purposes in the public interest, scientific or historical research purposes or statistical purposes.”
Newcastle University are considered a public authority under Schedule 1 of the Freedom of Information Act 2000. The research study is in the public interest given the large proportion of people who suffer from heart conditions associated with this treatment. It is essential to make sure that the operations offered within the NHS are best for patients and this processing is designed to inform decisions of this nature. To this end it meets the conditions outlined in Schedule 1 Part 1 (4) of the Data Protection Act 2018.
This study, the UK Mini Mitral Trial, will compare the two operations (sternotomy & mini thoracotomy) in 327 patients, to see how well they recover and return to normal activities. The trial's primary objective is to compare the two different types of surgery. The trial will include patients at NHS hospitals across England and Scotland, however data will only be requested for participants in England under this Agreement. Patients will be randomised (allocated) to undergo one of the operations. The trial is large enough to show which operation is better for patients and the NHS. Patients will be asked to take part in answering questions about their physical activities and quality of life before and after their operation. Researchers will also check other important factors to see how well patients recover, including how well their valve works up to twelve weeks and twelve months after surgery using a heart scan (called an echocardiogram). Any complications following a patient’s operation will be recorded from their medical records. The study will also calculate the costs of care for each operation by looking at medical records to see how often patients are seen in hospital after their operation. Patients who take part will attend hospital a few times in the first year, after this the study will continue to check their progress by reviewing their medical notes. The study will ask patients to confirm that they are happy that the study continues to look at their medical records, even after the trial is finished.
The study participants are 327 adult patients with degenerative mitral valve disease requiring MVr. The study has asked these participants for written consent to take part in the study. The UK Mini Mitral Trial began recruiting patients in 2016, and the last patient was recruited and randomised in 2021. There will be no further recruitment to the trial as the recruitment target has been met.
The trial is co-ordinated by the Newcastle Clinical Trials Unit, made up of staff employed by Newcastle University. The trial is sponsored by the South Tees Hospitals NHS Foundation Trust, where the Chief Investigator is a substantive employee; the Chief Investigator also has an honorary contract at Newcastle University, where he is Professor of Cardiac Surgery. Both Newcastle University and South Tees Hospitals NHS Foundation Trust are the Data Controllers for the data being requested from NHS Digital.
. Data processing will be conducted by Newcastle University and an independent panel of adjudicators:
* Statisticians employed by Durham University who hold honorary contracts with Newcastle University will review and analyse HES data remotely using a Newcastle University login at Durham University. No data will be downloaded to Durham University premises.
* Health Economists employed by Newcastle University will review and analyse HES data on Newcastle University premises.
* An independent panel of experts based at Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust (Data Processors) will review HES data at their local Trusts to help determine if events identified can be deemed mitral valve-related. The role of the independent expert panel will be to assess which use of health services is attributable or sequelae to the index surgery or underlying disease condition (e.g. surgical revision or complication, worsening mitral disease or infection) and/or which is unrelated.
Panel members may require access to unique study ID, age, sex and ethnicity when reviewing the data, however where possible data will be aggregated. An auditor or regulatory inspector may access trial data, as required.
Data Processors will access the data above remotely from Newcastle University's Data Safe Haven environment. .
Data Processing agreements have been put in place for each of the data processors listed above.
To support this work the data controllers requests historic annual data from 2016/17 onwards in addition to annual disseminations of the following datasets:
- Hospital Episode Statistics (HES) Accident and Emergency & Emergency Care Data Set (ECDS)
- Hospital Episode Statistics (HES) Outpatients,
- Hospital Episode Statistics (HES) Admitted Patient Care
- Civil Registration (Deaths) - Secondary Care Cut
This data will be linked to identifiable study data collected from participants who have consented to share this data. This data will be used to answer the following UK Mini Mitral trial secondary objectives through understanding patient journeys of participants, monitoring for instances of mortality:
- To compare mitral valve and mitral valve surgery related events and survival (morbidity and mortality) at various time points following index surgery.
- To determine if routinely collected data adequately captures mitral valve related events.
- To determine costs of the two operations, and any subsequent conditions over 52 weeks
- To model costs and QALYs (Quality Adjusted Life Years) over the patient lifetime.
- To model incremental cost per QALY gained over the patient lifetime
The UK Mini Mitral Trial is funded by the National Institute of Health Research – Health Technology Assessment Programme. The initial proposal of the trial was underpinned by robust patient and public involvement contributions including focus groups with patients to understand the need for the trial from their perspective, which has continued throughout the trial, including as part of the Trial Steering Committee where a patient sits. The study has also engaged with the national British Heart Foundation (BHF) PPI group and patients eagerly await the results of the trial. Further patient and public involvement is dependent on the outcomes of the trial linked to the processing specified in this agreement. The Chief Investigator for the study is involved in the National Cardiac Surgical Trials Initiative and the Clinical Study Group on minimally invasive surgery which has strong links to the national BHF PPI Group. This group was set up at the time of the BHF/James Lind Alliance Priority Setting Partnership in Cardiac surgery; there are 6 patients from the national BHF PPI group that are members of the minimally invasive Clinical Study Group. The national PPI group have had details of the trial discussed with them on a number of occasions, and the primary findings of the study have already been discussed with the national BHF PPI Group lead to ensure that findings can be conveyed both to patients who have taken part in the trial, but also to the wider public who may be considered for heart valve surgery in the future.
Processing activities
Newcastle University will provide NHS England with NHS number, Sex and Date of birth specific to participants of the study. This data has been collected from participants and stored in a Data Safe Haven within Newcastle University.
NHS England will flag participants within the HES, ECDS and Civil Registration data products requested by Newcastle University & South Tees Hospitals NHS Foundation Trust. Participant data will be linked to NHS England data and returned to Newcastle University for processing via Secure Electronic File Transfer (SEFT). Data will be downloaded by a named individual at Newcastle University and stored securely in the University’s Data Safe Haven. NHS England data will be linked to study data collected over the course of the trial directly from participants. The data will be processed within the Data Safe Haven.
- Hospital Episode Statistics will be processed to assist in identifying events within the participants health care records that could be attributed as related, contributing or and outcome of Mitral valve repair (MVr) surgery. Analysts will use the data to compare the treatments associated with MVr, validate how events associated with these treatments can be identified within the data and monitor the effectiveness & costs comparable between the treatments.
- Civil Registration - Deaths data will be utilised to identify instances of mortality of participants, linked to HES data to analyse and understand any relating factors.
The study will also NHS England data to National Institute for Cardiac Outcomes Research database (NICOR) data. This linkage will be to validate hospitals records and their outcomes and classify the relevant outcomes across mitral valve related events.
Data will be made available to Data Processors listed within this Data Sharing Agreement via remote access to Newcastle University’s Data Safe Haven secure environment. Data processors will be provided with secure access roles to the system. All access and processing of the data will be performed within the Newcastle University Data Safe Haven. Data processing is only carried out by substantive employees of the data processor(s) and or data controller(s) named within this agreement, and statisticians employed by Durham University and which hold honorary contracts with Newcastle University. Those accessing the data have been appropriately trained in data protection and confidentiality. Newcastle University will filter NHS England data, so that data processors and other partner organisations receive only the data required for their analyses.
- The project team employed by Newcastle University will have access to data received from NHS England and will be involved with analysis. This includes the Chief Investigator for the trial, trial managers, clinical trial administrator and Health Economist who will analyse the data to address the objectives outlined in this agreement.
- Data processing conducted by Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust will involve an independent panel of experts to review HES data at their local Trusts to help determine if events identified can be deemed mitral valve-related. The role of the independent panel of experts will be to review pseudonymised HES data to ensure there are no other clinical conditions (other than mitral valve disease) that may explain diagnoses.
Using a secure method of remote screen sharing from Newcastle University, pseudonymised data will be viewed by an independent panel of NHS-employed clinical adjudicators based at Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust.
Expected output
UPDATED OUTPUTS MAY 26
The research team are planning a comprehensive dissemination package that includes:
- Developing and submitting an NIHR Report that will be published.
- Aggregated findings will be widely publicised at national and international conferences (e.g. America College of Cardiology).
- Research findings will be published in high impact open access publications (New England Journal of Medicine [NEJM]/Lancet).
- To actively engage with policy makers and NICE to enable findings to be rapidly implemented in clinical practice.
- To continue to work with patients to develop patient facing materials that will convey the messages from the research that are important to patients - this may take the form of an animation. This will target both those who took part in the trial, and the wider patient groups as the study aims to create information accessible to all current and future patients requiring cardiac surgery.
Individual data will not be contained in outputs. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
The target date for dissemination of findings is summer of 2028 onwards.
The University of Newcastle anticipate that the findings of this study may have international reach. The operations performed in this trial are also conducted globally and as such research findings will have international relevance.
.........................................................................
The research team are planning a comprehensive dissemination package that includes:
- Developing and submitting an NIHR Report that will be published.
- Aggregated findings will be widely publicised at national and international conferences (e.g. America College of Cardiology).
- Research findings will be published in high impact open access publications (New England Journal of Medicine [NEJM]/Lancet).
- To actively engage with policy makers and NICE to enable findings to be rapidly implemented in clinical practice.
- To continue to work with patients to develop patient facing materials that will convey the messages from the research that are important to patients - this may take the form of an animation. This will target both those who took part in the trial, and the wider patient groups as the study aims to create information accessible to all current and future patients requiring cardiac surgery.
Individual data will not be contained in outputs. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
The target date for dissemination of findings is summer of 2028 onwards.
The University of Newcastle anticipate that the findings of this study may have international reach. The operations performed in this trial are also conducted globally and as such research findings will have international relevance.
Expected measurable benefits
UPDATED YIELDED BENEFITS MAY 2026:
The UK Mini Mitral trial aimed to answer the question of whether a minimally invasive surgical technique is superior to conventional sternotomy when performing mitral valve repair surgery in relation to rate of recovery. The initial results have already impacted patient care internationally and are now cited in the 2025 European guidelines for the treatment and management of valvular heart disease.
Every year approximately 2000 patients undergo mitral valve repair surgery in the NHS and this number continues to increase. The UK Mini Mitral trial expects the information obtained from this processing to be used to provide further updates to the NICE guideline: https://www.nice.org.uk/guidance/ng208 and to European guidelines and to support patients being offered safe, effective interventions for their mitral valve disease.
Whilst the primary trial results did not show superiority of the minimally invasive approach in recovery of physical function twelve weeks after surgery, the minimally invasive approach did achieve high rates and quality of valve repair and showed similar safety outcomes at 1 year. Findings from the longer-term routine data are therefore eagerly awaited.
Findings from this work may directly impact practice and policy in the UK, and internationally. In addition, the knowledge gained through this work could be used to design efficient and effective trials in the future that make appropriate use of routine data sets for the collection of outcome data. International dissemination will further ensure maximisation of the opportunity to change practice and policy once long-term findings are known.
..................................................................................
The UK Mini Mitral trial aims to answer the question of whether a minimally invasive surgical technique, is superior to conventional sternotomy when performing mitral valve repair surgery in relation to rate of recovery. The results hope to significantly impact patient care nationally and internationally. Indeed, the results are highly anticipated by the clinical community, and by NICE, who have already stated that its findings may influence the next set of clinical guidelines. Every year approximately 2000 patients undergo mitral valve repair surgery in the NHS and this number continues to increase. The UK Mini Mitral trial expects the information obtained from this processing to be used to update the NICE guideline: https://www.nice.org.uk/guidance/ng208 to support patients being offered a safe, effective intervention for their mitral valve disease with the shortest stay needed in hospital and shortest overall recovery time.
The minimally invasive approach has the potential to reduce post-operative complications, and thus hospital stay and overall recovery time to the benefit of patients and the NHS. However, there remains significant debate within the clinical community and uncertainty in the international literature about widespread adoption of minimally invasive surgery in the absence of definitive research evidence.
It is clear that findings may directly impact practice and policy in the UK, and internationally. In addition, the knowledge gained through this work could be used to design efficient and effective trials in the future that make appropriate use of routine data sets. The aim is to begin disseminating findings from the trial beginning in summer of 2023. Dissemination will continue beyond this date to ensure maximisation of the opportunity to change practice and policy once findings are known.
Benefits reported so far
The UK Mini Mitral trial aimed to answer the question of whether a minimally invasive surgical technique is superior to conventional sternotomy when performing mitral valve repair surgery in relation to rate of recovery. The initial results have already impacted patient care internationally and are now cited in the 2025 European guidelines for the treatment and management of valvular heart disease.
Every year approximately 2000 patients undergo mitral valve repair surgery in the NHS and this number continues to increase. The UK Mini Mitral trial expects the information obtained from this processing to be used to provide further updates to the NICE guideline: https://www.nice.org.uk/guidance/ng208 and to European guidelines and to support patients being offered safe, effective interventions for their mitral valve disease.
Whilst the primary trial results did not show superiority of the minimally invasive approach in recovery of physical function twelve weeks after surgery, the minimally invasive approach did achieve high rates and quality of valve repair and showed similar safety outcomes at 1 year. Findings from the longer-term routine data are therefore eagerly awaited.
Findings from this work may directly impact practice and policy in the UK, and internationally. In addition, the knowledge gained through this work could be used to design efficient and effective trials in the future that make appropriate use of routine data sets for the collection of outcome data. International dissemination will further ensure maximisation of the opportunity to change practice and policy once long-term findings are known.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(c)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Civil Registrations of Death | Identifiable | Sensitive | Ongoing | Consent (Reasonable Expectation) |
| Emergency Care Data Set (ECDS) | Identifiable | Non-Sensitive | Ongoing | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Accident and Emergency (HES A and E) | Identifiable | Non-Sensitive | Ongoing | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Identifiable | Non-Sensitive | Ongoing | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Outpatients (HES OP) | Identifiable | Non-Sensitive | Ongoing | Consent (Reasonable Expectation) |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were not applied to any of the 30 files released under this agreement, across every version. About opt-outs
No files recorded as released under the current version. 30 were released under earlier versions, shown in the version history.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-361864-N8P1S-v2.4 15 May 2026 to 14 May 2027
- Title
- Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 0
Datasets: Civil Registrations of Death; Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-361864-N8P1S-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2026-05-15 | |
| End date | 2027-05-14 | |
| Civil Registrations of Death: legal basis | Health and Social Care Act 2012 – s261(2)(c) | |
| Emergency Care Data Set (ECDS): legal basis | Health and Social Care Act 2012 – s261(2)(c) | |
| Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis | Health and Social Care Act 2012 – s261(2)(c) | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 – s261(2)(c) | |
| Hospital Episode Statistics Outpatients (HES OP): legal basis | Health and Social Care Act 2012 – s261(2)(c) |
Objective for processing
[7 paragraphs unchanged]
The trial is co-ordinated by the Newcastle Clinical Trials Unit, made up
[54 words unchanged]
are the Data Controllers for the data being requested from NHS Digital.
Data processing will be conducted by Newcastle University and an independent panel of adjudicators:
. Data processing will be conducted by Newcastle University and an independent panel of adjudicators:
[4 paragraphs unchanged]
Data Processors will access the data above remotely from Newcastle University's Data Safe Haven environment.
Data Processing agreements have been put in place for each of the data processors listed above.
.
Data Processing agreements have been put in place for each of the data processors listed above.
[12 paragraphs unchanged]
Expected output
UPDATED OUTPUTS MAY 26
[5 paragraphs unchanged]
- To continue to work with patients to develop patient facing materials
[43 words unchanged]
create information accessible to all current and future patients requiring cardiac surgery.
We have already forged close links with charities including Heart Valve Voice, to maximise the study's ability to reach patients with the findings.
[1 paragraph unchanged]
The target date for dissemination of findings is summer of
2023
2028
onwards.
[1 paragraph unchanged]
.........................................................................
The research team are planning a comprehensive dissemination package that includes:
- Developing and submitting an NIHR Report that will be published.
- Aggregated findings will be widely publicised at national and international conferences (e.g. America College of Cardiology).
- Research findings will be published in high impact open access publications (New England Journal of Medicine [NEJM]/Lancet).
- To actively engage with policy makers and NICE to enable findings to be rapidly implemented in clinical practice.
- To continue to work with patients to develop patient facing materials that will convey the messages from the research that are important to patients - this may take the form of an animation. This will target both those who took part in the trial, and the wider patient groups as the study aims to create information accessible to all current and future patients requiring cardiac surgery.
Individual data will not be contained in outputs. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
The target date for dissemination of findings is summer of 2028 onwards.
The University of Newcastle anticipate that the findings of this study may have international reach. The operations performed in this trial are also conducted globally and as such research findings will have international relevance.
Expected measurable benefits
UPDATED YIELDED BENEFITS MAY 2026: The UK Mini Mitral trial aimed to answer the question of whether a minimally invasive surgical technique is superior to conventional sternotomy when performing mitral valve repair surgery in relation to rate of recovery. The initial results have already impacted patient care internationally and are now cited in the 2025 European guidelines for the treatment and management of valvular heart disease. Every year approximately 2000 patients undergo mitral valve repair surgery in the NHS and this number continues to increase. The UK Mini Mitral trial expects the information obtained from this processing to be used to provide further updates to the NICE guideline: https://www.nice.org.uk/guidance/ng208 and to European guidelines and to support patients being offered safe, effective interventions for their mitral valve disease. Whilst the primary trial results did not show superiority of the minimally invasive approach in recovery of physical function twelve weeks after surgery, the minimally invasive approach did achieve high rates and quality of valve repair and showed similar safety outcomes at 1 year. Findings from the longer-term routine data are therefore eagerly awaited. Findings from this work may directly impact practice and policy in the UK, and internationally. In addition, the knowledge gained through this work could be used to design efficient and effective trials in the future that make appropriate use of routine data sets for the collection of outcome data. International dissemination will further ensure maximisation of the opportunity to change practice and policy once long-term findings are known. .................................................................................. [3 paragraphs unchanged]
Benefits reported
Not stated in the previous version; added here.
The UK Mini Mitral trial aimed to answer the question of whether a minimally invasive surgical technique is superior to conventional sternotomy when performing mitral valve repair surgery in relation to rate of recovery. The initial results have already impacted patient care internationally and are now cited in the 2025 European guidelines for the treatment and management of valvular heart disease.
Every year approximately 2000 patients undergo mitral valve repair surgery in the NHS and this number continues to increase. The UK Mini Mitral trial expects the information obtained from this processing to be used to provide further updates to the NICE guideline: https://www.nice.org.uk/guidance/ng208 and to European guidelines and to support patients being offered safe, effective interventions for their mitral valve disease.
Whilst the primary trial results did not show superiority of the minimally invasive approach in recovery of physical function twelve weeks after surgery, the minimally invasive approach did achieve high rates and quality of valve repair and showed similar safety outcomes at 1 year. Findings from the longer-term routine data are therefore eagerly awaited.
Findings from this work may directly impact practice and policy in the UK, and internationally. In addition, the knowledge gained through this work could be used to design efficient and effective trials in the future that make appropriate use of routine data sets for the collection of outcome data. International dissemination will further ensure maximisation of the opportunity to change practice and policy once long-term findings are known.
Unchanged: Processing activities.
DARS-NIC-361864-N8P1S-v1.2 10 May 2024 to 14 May 2026
- Title
- Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 6
Datasets: Civil Registrations of Death; Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-361864-N8P1S-v0.20
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-05-10 |
Benefits reported
Stated in the previous version and removed here.
Yielded Benefits is not a requirement for new applications.
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.
Objective for processing
Heart surgery to repair one of the valves in the heart (the mitral valve) is commonly performed in the NHS. Patients needing this operation sometimes suffer symptoms of shortness of breath (especially when exercising), tiredness, and swollen ankles, caused by the valve becoming leaky (mitral regurgitation), while other patients suffer very few symptoms. Both sets of patients are often of working age, so time away from their place of work can be difficult for a number of reasons. It is essential to make sure that the operations offered within the NHS are best for patients. To repair the valve, the operation usually involves cutting the breastbone completely (from the collar bone to the bottom of the breastbone); a sternotomy. However, an operation has been developed which means that the valve can be repaired using a much smaller cut on the side of the chest; a mini thoracotomy. Mitral valve repair (MVr) surgery for mitral valve regurgitation was being performed more frequently with patient numbers increasing by a third between 2003 and 2012. In recent years, figures of surgeries have remained at a similar level and whilst have shown declines at times when COVID-19 admissions have peaked, surgery figures have shown further sharp increases once COVID-19 admissions decreased and show a continued need with the patient population for treatment. This rise is expected to continue in an ageing population, alongside a recognition in the international guidance that asymptomatic patients may also benefit from early surgery. Together this presents a growing patient need to ensure treatment is considered and delivered as effectively as possible.
The lawful basis for carrying out this study under UK GDPR is:
- Article 6 (1)(e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller͟”.
- Article 9 (2)(j) – “processing is necessary for achieving purposes in the public interest, scientific or historical research purposes or statistical purposes.”
Newcastle University are considered a public authority under Schedule 1 of the Freedom of Information Act 2000. The research study is in the public interest given the large proportion of people who suffer from heart conditions associated with this treatment. It is essential to make sure that the operations offered within the NHS are best for patients and this processing is designed to inform decisions of this nature. To this end it meets the conditions outlined in Schedule 1 Part 1 (4) of the Data Protection Act 2018.
This study, the UK Mini Mitral Trial, will compare the two operations (sternotomy & mini thoracotomy) in 327 patients, to see how well they recover and return to normal activities. The trial's primary objective is to compare the two different types of surgery. The trial will include patients at NHS hospitals across England and Scotland, however data will only be requested for participants in England under this Agreement. Patients will be randomised (allocated) to undergo one of the operations. The trial is large enough to show which operation is better for patients and the NHS. Patients will be asked to take part in answering questions about their physical activities and quality of life before and after their operation. Researchers will also check other important factors to see how well patients recover, including how well their valve works up to twelve weeks and twelve months after surgery using a heart scan (called an echocardiogram). Any complications following a patient’s operation will be recorded from their medical records. The study will also calculate the costs of care for each operation by looking at medical records to see how often patients are seen in hospital after their operation. Patients who take part will attend hospital a few times in the first year, after this the study will continue to check their progress by reviewing their medical notes. The study will ask patients to confirm that they are happy that the study continues to look at their medical records, even after the trial is finished.
The study participants are 327 adult patients with degenerative mitral valve disease requiring MVr. The study has asked these participants for written consent to take part in the study. The UK Mini Mitral Trial began recruiting patients in 2016, and the last patient was recruited and randomised in 2021. There will be no further recruitment to the trial as the recruitment target has been met.
The trial is co-ordinated by the Newcastle Clinical Trials Unit, made up of staff employed by Newcastle University. The trial is sponsored by the South Tees Hospitals NHS Foundation Trust, where the Chief Investigator is a substantive employee; the Chief Investigator also has an honorary contract at Newcastle University, where he is Professor of Cardiac Surgery. Both Newcastle University and South Tees Hospitals NHS Foundation Trust are the Data Controllers for the data being requested from NHS Digital. Data processing will be conducted by Newcastle University and an independent panel of adjudicators:
* Statisticians employed by Durham University who hold honorary contracts with Newcastle University will review and analyse HES data remotely using a Newcastle University login at Durham University. No data will be downloaded to Durham University premises.
* Health Economists employed by Newcastle University will review and analyse HES data on Newcastle University premises.
* An independent panel of experts based at Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust (Data Processors) will review HES data at their local Trusts to help determine if events identified can be deemed mitral valve-related. The role of the independent expert panel will be to assess which use of health services is attributable or sequelae to the index surgery or underlying disease condition (e.g. surgical revision or complication, worsening mitral disease or infection) and/or which is unrelated.
Panel members may require access to unique study ID, age, sex and ethnicity when reviewing the data, however where possible data will be aggregated. An auditor or regulatory inspector may access trial data, as required.
Data Processors will access the data above remotely from Newcastle University's Data Safe Haven environment. Data Processing agreements have been put in place for each of the data processors listed above.
To support this work the data controllers requests historic annual data from 2016/17 onwards in addition to annual disseminations of the following datasets:
- Hospital Episode Statistics (HES) Accident and Emergency & Emergency Care Data Set (ECDS)
- Hospital Episode Statistics (HES) Outpatients,
- Hospital Episode Statistics (HES) Admitted Patient Care
- Civil Registration (Deaths) - Secondary Care Cut
This data will be linked to identifiable study data collected from participants who have consented to share this data. This data will be used to answer the following UK Mini Mitral trial secondary objectives through understanding patient journeys of participants, monitoring for instances of mortality:
- To compare mitral valve and mitral valve surgery related events and survival (morbidity and mortality) at various time points following index surgery.
- To determine if routinely collected data adequately captures mitral valve related events.
- To determine costs of the two operations, and any subsequent conditions over 52 weeks
- To model costs and QALYs (Quality Adjusted Life Years) over the patient lifetime.
- To model incremental cost per QALY gained over the patient lifetime
The UK Mini Mitral Trial is funded by the National Institute of Health Research – Health Technology Assessment Programme. The initial proposal of the trial was underpinned by robust patient and public involvement contributions including focus groups with patients to understand the need for the trial from their perspective, which has continued throughout the trial, including as part of the Trial Steering Committee where a patient sits. The study has also engaged with the national British Heart Foundation (BHF) PPI group and patients eagerly await the results of the trial. Further patient and public involvement is dependent on the outcomes of the trial linked to the processing specified in this agreement. The Chief Investigator for the study is involved in the National Cardiac Surgical Trials Initiative and the Clinical Study Group on minimally invasive surgery which has strong links to the national BHF PPI Group. This group was set up at the time of the BHF/James Lind Alliance Priority Setting Partnership in Cardiac surgery; there are 6 patients from the national BHF PPI group that are members of the minimally invasive Clinical Study Group. The national PPI group have had details of the trial discussed with them on a number of occasions, and the primary findings of the study have already been discussed with the national BHF PPI Group lead to ensure that findings can be conveyed both to patients who have taken part in the trial, but also to the wider public who may be considered for heart valve surgery in the future.
Expected output
The research team are planning a comprehensive dissemination package that includes:
- Developing and submitting an NIHR Report that will be published.
- Aggregated findings will be widely publicised at national and international conferences (e.g. America College of Cardiology).
- Research findings will be published in high impact open access publications (New England Journal of Medicine [NEJM]/Lancet).
- To actively engage with policy makers and NICE to enable findings to be rapidly implemented in clinical practice.
- To continue to work with patients to develop patient facing materials that will convey the messages from the research that are important to patients - this may take the form of an animation. This will target both those who took part in the trial, and the wider patient groups as the study aims to create information accessible to all current and future patients requiring cardiac surgery. We have already forged close links with charities including Heart Valve Voice, to maximise the study's ability to reach patients with the findings.
Individual data will not be contained in outputs. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
The target date for dissemination of findings is summer of 2023 onwards.
The University of Newcastle anticipate that the findings of this study may have international reach. The operations performed in this trial are also conducted globally and as such research findings will have international relevance.
DARS-NIC-361864-N8P1S-v0.20 15 May 2023 to 14 May 2026
- Title
- Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).
- Commercial
- No
- Sublicensing
- No
- Datasets
- 5
- Files released
- 24
Datasets: Civil Registrations of Death; Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
Objective for processing
Heart surgery to repair one of the valves in the heart (the mitral valve) is commonly performed in the NHS. Patients needing this operation sometimes suffer symptoms of shortness of breath (especially when exercising), tiredness, and swollen ankles, caused by the valve becoming leaky (mitral regurgitation), while other patients suffer very few symptoms. Both sets of patients are often of working age, so time away from their place of work can be difficult for a number of reasons. It is essential to make sure that the operations offered within the NHS are best for patients. To repair the valve, the operation usually involves cutting the breastbone completely (from the collar bone to the bottom of the breastbone); a sternotomy. However, an operation has been developed which means that the valve can be repaired using a much smaller cut on the side of the chest; a mini thoracotomy. Mitral valve repair (MVr) surgery for mitral valve regurgitation was being performed more frequently with patient numbers increasing by a third between 2003 and 2012. In recent years, figures of surgeries have remained at a similar level and whilst have shown declines at times when COVID-19 admissions have peaked, surgery figures have shown further sharp increases once COVID-19 admissions decreased and show a continued need with the patient population for treatment. This rise is expected to continue in an ageing population, alongside a recognition in the international guidance that asymptomatic patients may also benefit from early surgery. Together this presents a growing patient need to ensure treatment is considered and delivered as effectively as possible.
The lawful basis for carrying out this study under UK GDPR is:
- Article 6 (1)(e) – “processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller͟”.
- Article 9 (2)(j) – “processing is necessary for achieving purposes in the public interest, scientific or historical research purposes or statistical purposes.”
Newcastle University are considered a public authority under Schedule 1 of the Freedom of Information Act 2000. The research study is in the public interest given the large proportion of people who suffer from heart conditions associated with this treatment. It is essential to make sure that the operations offered within the NHS are best for patients and this processing is designed to inform decisions of this nature. To this end it meets the conditions outlined in Schedule 1 Part 1 (4) of the Data Protection Act 2018.
This study, the UK Mini Mitral Trial, will compare the two operations (sternotomy & mini thoracotomy) in 327 patients, to see how well they recover and return to normal activities. The trial's primary objective is to compare the two different types of surgery. The trial will include patients at NHS hospitals across England and Scotland, however data will only be requested for participants in England under this Agreement. Patients will be randomised (allocated) to undergo one of the operations. The trial is large enough to show which operation is better for patients and the NHS. Patients will be asked to take part in answering questions about their physical activities and quality of life before and after their operation. Researchers will also check other important factors to see how well patients recover, including how well their valve works up to twelve weeks and twelve months after surgery using a heart scan (called an echocardiogram). Any complications following a patient’s operation will be recorded from their medical records. The study will also calculate the costs of care for each operation by looking at medical records to see how often patients are seen in hospital after their operation. Patients who take part will attend hospital a few times in the first year, after this the study will continue to check their progress by reviewing their medical notes. The study will ask patients to confirm that they are happy that the study continues to look at their medical records, even after the trial is finished.
The study participants are 327 adult patients with degenerative mitral valve disease requiring MVr. The study has asked these participants for written consent to take part in the study. The UK Mini Mitral Trial began recruiting patients in 2016, and the last patient was recruited and randomised in 2021. There will be no further recruitment to the trial as the recruitment target has been met.
The trial is co-ordinated by the Newcastle Clinical Trials Unit, made up of staff employed by Newcastle University. The trial is sponsored by the South Tees Hospitals NHS Foundation Trust, where the Chief Investigator is a substantive employee; the Chief Investigator also has an honorary contract at Newcastle University, where he is Professor of Cardiac Surgery. Both Newcastle University and South Tees Hospitals NHS Foundation Trust are the Data Controllers for the data being requested from NHS Digital. Data processing will be conducted by Newcastle University and an independent panel of adjudicators:
* Statisticians employed by Durham University who hold honorary contracts with Newcastle University will review and analyse HES data remotely using a Newcastle University login at Durham University. No data will be downloaded to Durham University premises.
* Health Economists employed by Newcastle University will review and analyse HES data on Newcastle University premises.
* An independent panel of experts based at Oxford University Hospitals NHS Foundation Trust, University Hospitals Sussex NHS Foundation Trust and The Royal Wolverhampton NHS Trust (Data Processors) will review HES data at their local Trusts to help determine if events identified can be deemed mitral valve-related. The role of the independent expert panel will be to assess which use of health services is attributable or sequelae to the index surgery or underlying disease condition (e.g. surgical revision or complication, worsening mitral disease or infection) and/or which is unrelated.
Panel members may require access to unique study ID, age, sex and ethnicity when reviewing the data, however where possible data will be aggregated. An auditor or regulatory inspector may access trial data, as required.
Data Processors will access the data above remotely from Newcastle University's Data Safe Haven environment. Data Processing agreements have been put in place for each of the data processors listed above.
To support this work the data controllers requests historic annual data from 2016/17 onwards in addition to annual disseminations of the following datasets:
- Hospital Episode Statistics (HES) Accident and Emergency & Emergency Care Data Set (ECDS)
- Hospital Episode Statistics (HES) Outpatients,
- Hospital Episode Statistics (HES) Admitted Patient Care
- Civil Registration (Deaths) - Secondary Care Cut
This data will be linked to identifiable study data collected from participants who have consented to share this data. This data will be used to answer the following UK Mini Mitral trial secondary objectives through understanding patient journeys of participants, monitoring for instances of mortality:
- To compare mitral valve and mitral valve surgery related events and survival (morbidity and mortality) at various time points following index surgery.
- To determine if routinely collected data adequately captures mitral valve related events.
- To determine costs of the two operations, and any subsequent conditions over 52 weeks
- To model costs and QALYs (Quality Adjusted Life Years) over the patient lifetime.
- To model incremental cost per QALY gained over the patient lifetime
The UK Mini Mitral Trial is funded by the National Institute of Health Research – Health Technology Assessment Programme. The initial proposal of the trial was underpinned by robust patient and public involvement contributions including focus groups with patients to understand the need for the trial from their perspective, which has continued throughout the trial, including as part of the Trial Steering Committee where a patient sits. The study has also engaged with the national British Heart Foundation (BHF) PPI group and patients eagerly await the results of the trial. Further patient and public involvement is dependent on the outcomes of the trial linked to the processing specified in this agreement. The Chief Investigator for the study is involved in the National Cardiac Surgical Trials Initiative and the Clinical Study Group on minimally invasive surgery which has strong links to the national BHF PPI Group. This group was set up at the time of the BHF/James Lind Alliance Priority Setting Partnership in Cardiac surgery; there are 6 patients from the national BHF PPI group that are members of the minimally invasive Clinical Study Group. The national PPI group have had details of the trial discussed with them on a number of occasions, and the primary findings of the study have already been discussed with the national BHF PPI Group lead to ensure that findings can be conveyed both to patients who have taken part in the trial, but also to the wider public who may be considered for heart valve surgery in the future.
Expected output
The research team are planning a comprehensive dissemination package that includes:
- Developing and submitting an NIHR Report that will be published.
- Aggregated findings will be widely publicised at national and international conferences (e.g. America College of Cardiology).
- Research findings will be published in high impact open access publications (New England Journal of Medicine [NEJM]/Lancet).
- To actively engage with policy makers and NICE to enable findings to be rapidly implemented in clinical practice.
- To continue to work with patients to develop patient facing materials that will convey the messages from the research that are important to patients - this may take the form of an animation. This will target both those who took part in the trial, and the wider patient groups as the study aims to create information accessible to all current and future patients requiring cardiac surgery. We have already forged close links with charities including Heart Valve Voice, to maximise the study's ability to reach patients with the findings.
Individual data will not be contained in outputs. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
The target date for dissemination of findings is summer of 2023 onwards.
The University of Newcastle anticipate that the findings of this study may have international reach. The operations performed in this trial are also conducted globally and as such research findings will have international relevance.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
-
June 2023 —
first listed. 1 version: DARS-NIC-361864-N8P1S-v0.20
-
December 2023
Renamed Applicant organisation: Newcastle University now named University of Newcastle upon Tyne. Not counted as a change.Renamed Data controllers: Newcastle University now named University of Newcastle upon Tyne. Not counted as a change.
-
July 2024
1 version added: DARS-NIC-361864-N8P1S-v1.2
-
July 2026
1 version added: DARS-NIC-361864-N8P1S-v2.4
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-361864-N8P1S, “Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-361864-n8p1s/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-361864-N8P1S to see the original rows.