Comparing early mitral valve repair to watchful waiting for asymptomatic severe mitral regurgitation
Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse
This study is testing if early surgery for the mitral valve can help people with severe mitral regurgitation live longer and healthier compared to just keeping an eye on their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 2 sites (Amiens and 1 other locations) |
| Trial ID | NCT03389542 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of early surgical repair of the mitral valve in asymptomatic patients with severe degenerative mitral regurgitation against a conservative management approach known as watchful waiting. Patients in the experimental group will undergo surgery within three months of randomization, while those in the control group will be monitored with regular clinical interviews and echocardiograms. The study seeks to determine whether early intervention can reduce all-cause mortality and cardiovascular morbidity compared to conservative management. Follow-up assessments will occur at discharge, six months, and annually thereafter.
Who should consider this trial
Good fit: Ideal candidates include asymptomatic individuals with severe degenerative mitral regurgitation and preserved left ventricular function.
Not a fit: Patients with significant comorbidities, prior cardiac surgeries, or those with symptomatic mitral regurgitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting early surgical intervention, potentially improving survival and quality of life for patients with severe mitral regurgitation.
How similar studies have performed: While there is ongoing debate regarding the timing of surgery for asymptomatic patients, this trial addresses a gap in existing research, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms * Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography * LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm * Sinus rhythm on the inclusion ECG * Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography. * High probability of mitral valve repair * EuroSCORE II ≤ 3% Exclusion Criteria: * Mitral stenosis or \> mild aortic valve disease (stenosis or regurgitation) * Congenital heart disease (except patent foramen ovale or atrial septal defect) * Patients with cardiac prostheses * Previous myocardial infarction * Previous cardiac surgery * Extra cardiac comorbidity with life expectancy \< 5 years * Recent history of psychiatric disease (including drug or alcohol abuse) * Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial
Where this trial is running
Amiens and 1 other locations
- CHU Amiens-Picardie — Amiens, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
Study contacts
- Principal investigator: Christophe TRIBOUILLOY, MD, PhD — CHU Amiens
- Study coordinator: Christophe TRIBOUILLOY, MD, phD
- Email: tribouilloy.christophe@chu-amiens.fr
- Phone: 322 087 250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.