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

Recruitingn/aAges 18 Years - 75 YearsAllUMC Utrecht
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In plain words

What the trial is, and whether it could suit you

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 manageme

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 18-75 years. * Asymptomatic patients. "Asymptomatic" is defined as absence of subjective limitations of exercise capacity or complaints expressed by the patient and confirmed by the treating cardiologist. * Severe organic mitral valve regurgitation. "Severe organic mitral valve regurgitation" is defined as non-ischemic mitral valve regurgitation with an organic cause (intrinsic valve lesion) as determined by echocardiographic core-lab reading based on the criteria for definition of severe MR as issued by the ESC guidelines \[4\]. For practical reasons, referring cardiologists can use an ESC guidelines based index that was validated in the investigator's core-lab (Jansen et al, Practical echocardiographic semi-quantitative scoring system to determine severity of mitral regurgitation. Abstract presentation at ESC EUROECHO Congress 2011 and annual spring congress 2012 Netherlands Society of Cardiology). * Preserved left ventricular function, "Preserved left ventricular function" is defined as left ventricular ejection fraction \>60% and left ventricular end-systolic dimension \<45 mm (no indexed value, measured by echocardiography). * The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon. Exclusion Criteria: * Pulmonary hypertension (\>50 mmHg at rest). * Atrial fibrillation, either on 12-lead ECG or holter-monitoring. * Physical inability as determined by the heart team to undergo surgery. * Other life-threatening morbidity. * Higher expected surgical risks in advance, according to the dedicated heart team. * Patients with moderate to severe kidney disease (estimated glomerular filtration rate (eGFR) less than 30 mL/min). * Flail leaflet together with a left ventricular end systolic diameter (LVESD) โ‰ฅ40 mm (no indexed value)
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What it tests

  • Mitral valve repair
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Where

6 sites
Amsterdam Medical Center (AMC)
Amsterdam, Netherlands
Amphia Breda
Breda, Netherlands
Medisch Spectrum Twente (MST)
Enschede, Netherlands
Leiden University Medical Center (LUMC)
Leiden, Netherlands
Maastricht UMC
Maastricht, Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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