Status:
UNKNOWN
Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 inte...
Detailed Description
Experimental group: In patients randomized to early mitral valve repair, surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months a...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT03389542
Start Date
April 10 2018
End Date
January 1 2026
Last Update
June 8 2018
Active Locations (2)
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1
CHU Amiens-Picardie
Amiens, France, 80054
2
Centre Cardiologique du Nord
Saint-Denis, France, 93200