Actively Recruiting
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-05-13
424
Participants Needed
2
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking. The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.
CONDITIONS
Official Title
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Asymptomatic patients confirmed by history or exercise test if needed
- Severe (grade IV) degenerative mitral regurgitation due to leaflet prolapse confirmed by echocardiography
- Left ventricular ejection fraction of 60% or higher by Simpson biplane method
- Left ventricular end-systolic diameter of 40 mm or less by echocardiography
- Sinus rhythm on the inclusion ECG
- Pulmonary artery pressure of 50 mmHg or less by Doppler echocardiography
- High probability of successful mitral valve repair
- EuroSCORE II of 3% or less
You will not qualify if you...
- Mitral stenosis or more than mild aortic valve disease (stenosis or regurgitation)
- Congenital heart disease except patent foramen ovale or atrial septal defect
- Presence of cardiac prostheses
- Previous myocardial infarction
- Previous cardiac surgery
- Other serious health conditions with life expectancy less than 5 years
- Recent psychiatric disease including drug or alcohol abuse
- Current treatment with an investigational intervention or planned participation in another intervention study during this trial
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHU Amiens-Picardie
Amiens, France, 80054
Actively Recruiting
2
Centre Cardiologique du Nord
Saint-Denis, France, 93200
Actively Recruiting
Research Team
C
Christophe TRIBOUILLOY, MD, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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