Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse Clinical Trial
Official title:
Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse
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.
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 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.
Control group: Patients randomized to initial conservative management will be followed up by
clinical interview and echocardiography every 6 months. Patients will be instructed to report
any change in functional status in a prompt manner. Surgery will be indicated at the onset of
symptoms or if one or more of the following occur during follow-up: LV end-systolic diameter
>40mm, LV ejection fraction <60%, recurrent atrial fibrillation, or resting systolic
pulmonary artery pressure >50mmHg.
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