Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation (Dutch-AMR)
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|ClinicalTrials.gov Identifier: NCT03975998|
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 6, 2019
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 . 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 ), it has proven to be eventually associated with good perioperative and postoperative outcome when careful follow-up is being carried out .
To compare early MV repair versus watchful waiting in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.
Multicenter, registry trial.
250 Asymptomatic patients (18-75 years old) with severe organic MV regurgitation and preserved left ventricular function. The current European Society of Cardiology (ESC) guidelines on Valvular Heart Disease will be applied . These guidelines are also used in the Netherlands. Accordingly, patients with an indication for MV surgery will not be included.
Intervention will be early MV repair compared to a watchful waiting strategy.
|Condition or disease||Intervention/treatment|
|Mitral Regurgitation||Procedure: Mitral valve repair|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Dutch-AMR Study: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation and Preserved Ejection Fraction: a Multicenter Registry Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||October 2031|
Aymptomatic patients with severe mitral regurgitation
Watchful waiting Early Surgery
Procedure: Mitral valve repair
Minimally invasive repair of severe organic mitral regurgiation
- Time to event: cardiovascular mortality, congestive heart failure, hospitalization, class I or class IIa indication for MV surgery [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975998
|Amsterdam Medical Center (AMC)||Recruiting|
|Contact: Matthijs Boekholdt firstname.lastname@example.org|
|Sub-Investigator: Jolanda Kluin|
|Principal Investigator: Matthijs Boekholdt|
|Sub-Investigator: Rene van den Brink|
|Contact: Jeroen Schaap email@example.com|
|Principal Investigator: Jeroen Schaap, MD|
|Medisch Spectrum Twente (MST)||Recruiting|
|Contact: Lodewijk Wagenaar L.Wagenaar@mst.nl|
|Principal Investigator: Lodewijk Wagenaar|
|Leiden University Medical Center (LUMC)||Active, not recruiting|
|Contact: Bas Streukens firstname.lastname@example.org|
|University Medical Center Utrecht (UMC Utrecht)||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Contact: Steven AJ Chamuleau, MD, PhD 0031 88 75 59801 S.A.J.Chamuleau@umcutrecht.nl|
|Principal Investigator: Steven AJ Chamuleau, MD, PhD|
|Sub-Investigator: Einar A Hart, MD|
|Sub-Investigator: Maarten Jan M Cramer, MD, PhD|