Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation

Recruiting now · Not applicable

Conditions studied: Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

In brief

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.

Key facts

Study ID

NCT03389542

Run by

Centre Hospitalier Universitaire, Amiens

People needed

424

Starts

2018-04-10

Expected to finish

2033-04-10

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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 it is running

• CHU Amiens-Picardie — Amiens, France (enrolling)
• Centre Cardiologique du Nord — Saint-Denis, France (enrolling)

Full record on ClinicalTrials.gov

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