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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgery
  • Clinical interview and echocardiography

Treatment groups

424 Participants
are divided into 2 treatment groups