MedTrace Logo

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

NCT03389542 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2026-05-13

No results posted yet for this study

Summary

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

  • Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

Interventions

PROCEDURE

Surgery

Early mitral valve repair

OTHER

Clinical interview and echocardiography

Clinical interview and echocardiography every 6 months.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Christophe TRIBOUILLOY, MD, PhD · CHU Amiens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2033-04-10
Completion
2033-04-10

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389542 on ClinicalTrials.gov