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Study identifier: NCT03389542 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse  ·  Sponsor: Centre Hospitalier Universitaire, Amiens

PhaseNA
Planned participants424
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Christophe TRIBOUILLOY, MD, phD  ·  322 087 250  ·  tribouilloy.christophe@chu-amiens.fr

Always discuss trial participation with your own doctor first.

Locations (2)

CHU Amiens-PicardieAmiens, FranceRecruiting
Centre Cardiologique du NordSaint-Denis, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT03389542