Mitral Valve Insufficiency Clinical Trial
Official title:
Dutch AMR; Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation; a Multicenter, Randomised Trial.
The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.
Severe asymptomatic organic mitral valve (MV) regurgitation with preserved left ventricular
(LV) function is a challenging clinical entity as data on the recommended treatment strategy
for these patients are scarce and conflicting, which is reflected in current guidelines.
European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly
echocardiography, whilst American guidelines are more in favour of early surgery to
reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent
future LV dysfunction and complaints.
A number of non-randomised trials show a favourable outcome of early surgery and the early
surgery strategy has shown to be associated with improved long-term survival, decreased
cardiac mortality and decreased morbidity compared with the conservative management
[citations 1-3]. On the other hand, non-randomised trials describe also that a conservative
strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is
performed in this population it has proven to be eventually associated with good
perioperative and postoperative outcome in 50% of the patients at 10 years when careful
follow-up is being carried out [citation 4]. Non-randomised trials inherently have a number
of drawbacks. A randomised trial comparing both strategies and objectivising the best
treatment strategy has never been performed.
The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective,
randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients
with severe organic MV regurgitation and preserved LV function [citation 5, 6].
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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