Informations générales (source: ClinicalTrials.gov)
Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse (REVERSE-MR)
Interventional
N/A
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
avril 2018
janvier 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE CARDIOLOGIQUE DU NORD | Thomas GOISSEN | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Amiens-Picardie - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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%
- 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%
- 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