Degenerative mitral valve disease Circulatory System
Conditions
Interventions
Patients are randomised to one of two groups. Those in group 1 receive mitral valve repair surgery by thoracosopically-guided right minithoracotomy (intervention group). Those in group 2 receive mitra
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult (=18 years old at consent) patients with degenerative mitral valve disease, requiring isolated MVr (patients requiring concomitant surgery for Atrial Fibrillation and/or Patent Foramen Ovale (PFO) closure will be included) 2. Written informed consent 3. Fit for cardiac surgery and cardiopulmonary bypass
Exclusion criteria
Exclusion criteria: 1. Concomitant cardiac surgery other than AF ablation and PFO closure 2. Requiring mitral valve replacement 3. Acute infective endocarditis 4. Emergency or salvage surgery 5. Only conventional median sternotomy or only minimally invasive surgery indicated 6. Pregnant* 7. Currently participating in another interventional clinical trial 8. Four weeks or more as an inpatient prior to randomisation 9. Previous cardiac surgery *Female patients between the ages of 18 and 50 will receive a pregnancy test at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the SF-36v2 physical functioning scale at 12 weeks post-surgery. The SF-36v2 is a generic multi-dimensional and validated instrument consisting of eight multi-item components representing physical function, social function, role limitation attributable to physical problems, role limitation attributable to emotional problems, mental health, energy, pain, general health perception. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Level and variability in physical activity: measured using one week of accelerometer measurements at 7 time points (baseline, and 6, 12, 18, 24, 38 and 52 weeks following index surgery) 2. Quality of sleep: measured using one week of accelerometer measurements at 7 time points (baseline, and 6, 12, 18, 24, 38 and 52 weeks following index surgery) 3. Surgical outcomes (including duration of operation, cardiopulmonary bypass times, anaesthetic regime, protocol adherence), measured using data collected at the time of index surgery 4. Costs, including intervention-specific estimates, of the two operations, measured using data collected at the time of index surgery 5. Mitral valve related events determined using HES, NICOR, and medical record data, measured using adverse event data collected for 52 weeks within the trial, and through requests to HSCIC and NICOR for event data 6. Left ventricular volumes and function, mitral regurgitation, right heart function, and pulmonary artery pressure, measured by Echocardiograms at baseline, post-operatively and at 52 weeks following index surgery 7. Survival Measured throughout the trial and using ONS data 8. Physical functioning using SF-36v2, measured using the SF-36v2 questionnaire administered at 7 time points (baseline, and 6, 12, 18, 24, 38 and 52 weeks following index surgery) 9. Quality of life using SF-36v2 and EQ-5D-5L, measured using the SF-36v2 and EQ-5D-5L questionnaires administered at 7 time points (baseline, and 6, 12, 18, 24, 38 and 52 weeks following index surgery) 10. Adverse Events and Serious Adverse Events, measured throughout the trial using a combination of patient reported events and data provided by HSCIC and NICOR 11. Health care utilisation, measured using patient reported health care utilisation questionnaires at 6, 12, 18, 24, 38 and 52 weeks following index surgery 12. Wound pain, measured using an 11 point VAS scale at 3 days, 6 weeks and 12 weeks following index surgery 13. NYHA class, measured | — |
Countries
England, United Kingdom
Outcome results
None listed