Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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%

Locations
Other Locations
France
CHU Amiens-Picardie
RECRUITING
Amiens
Centre Cardiologique du Nord
RECRUITING
Saint-denis
Contact Information
Primary
Christophe TRIBOUILLOY, MD, phD
tribouilloy.christophe@chu-amiens.fr
322 087 250
Time Frame
Start Date: 2018-04-10
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 424
Treatments
Experimental: Early mitral valve repair
Surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.
Active_comparator: Conservative management
Patients will be followed up by clinical interview and echocardiography every 6 months.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov