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Study identifier: NCT03975998 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation

Condition: Mitral Regurgitation  ·  Sponsor: UMC Utrecht

PhaseN/A
Planned participants500
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Rationale: 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: in the study of Enriquez-Sarano et al. for instance, 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 \[1\]. 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 (50% at 10 years follow-up according to Rosenhek et al \[2\]), it has proven to be eventually associated with good perioperative and postoperative outcome when careful follow-up is being carried out \[2\]. Objective: To compare early MV repair versus watchful waiting in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function. Study design: …

This description comes directly from the study's public registry record.

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Locations (6)

Amsterdam Medical Center (AMC)Amsterdam, NetherlandsRecruiting
Amphia BredaBreda, NetherlandsRecruiting
Medisch Spectrum Twente (MST)Enschede, NetherlandsRecruiting
Leiden University Medical Center (LUMC)Leiden, NetherlandsActive Not Recruiting
Maastricht UMCMaastricht, NetherlandsRecruiting
University Medical Center Utrecht (UMC Utrecht)Utrecht, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT03975998