Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2013-02-28
2021-02-28
Brief Summary
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Detailed Description
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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 \[citation 5, 6\].
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early mitral valve repair
Early mitral valve repair
Early mitral valve repair
Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.
Watchful waiting
Watchful waiting
Watchful waiting
In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.
Interventions
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Watchful waiting
In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.
Early mitral valve repair
Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.
Eligibility Criteria
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Inclusion Criteria
* Severe organic mitral valve regurgitation.
* Preserved left ventricular function (left ventricular ejection fraction \>60% and left ventricular end-systolic dimension ≤45 mm)
* The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon
Exclusion Criteria
* Atrial fibrillation
* 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
* Moderate to severe kidney disease (eGFR less than 30 mL/min)
* Flail leaflet together with a left ventricular end systolic diameter (LVESD) \>40 mm
18 Years
75 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
The Interuniversity Cardiology Institute of the Netherlands
OTHER_GOV
WCN, Dutch Network for Cardiovascular Research
UNKNOWN
UMC Utrecht
OTHER
Responsible Party
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S.A.J. Chamuleau
MD, PhD
Principal Investigators
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Steven AJ Chamuleau, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Utrecht (UMC Utrecht)
Jolanda Kluin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Utrecht (UMC Utrecht)
Robert JM Klautz, Prof. MD PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center (LUMC Leiden)
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Utrecht, Netherlands
Amsterdam Medisch Centrum
Amsterdam, , Netherlands
Amphia Hospital
Breda, , Netherlands
Countries
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References
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Ling LH, Enriquez-Sarano M, Seward JB, Orszulak TA, Schaff HV, Bailey KR, Tajik AJ, Frye RL. Early surgery in patients with mitral regurgitation due to flail leaflets: a long-term outcome study. Circulation. 1997 Sep 16;96(6):1819-25. doi: 10.1161/01.cir.96.6.1819.
Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.
Chenot F, Montant P, Vancraeynest D, Pasquet A, Gerber B, Noirhomme PH, El Khoury G, Vanoverschelde JL. Long-term clinical outcome of mitral valve repair in asymptomatic severe mitral regurgitation. Eur J Cardiothorac Surg. 2009 Sep;36(3):539-45. doi: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.
Rosenhek R, Rader F, Klaar U, Gabriel H, Krejc M, Kalbeck D, Schemper M, Maurer G, Baumgartner H. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation. 2006 May 9;113(18):2238-44. doi: 10.1161/CIRCULATIONAHA.105.599175. Epub 2006 May 1.
Tietge WJ, de Heer LM, van Hessen MW, Jansen R, Bots ML, van Gilst W, Schalij M, Klautz RJ, Van den Brink RB, Van Herwerden LA, Doevendans PA, Chamuleau SA, Kluin J. Early mitral valve repair versus watchful waiting in patients with severe asymptomatic organic mitral regurgitation; rationale and design of the Dutch AMR trial, a multicenter, randomised trial. Neth Heart J. 2012 Mar;20(3):94-101. doi: 10.1007/s12471-012-0249-y.
Jansen R, Kluin J, Chamuleau SA. Research versus clinical practice in asymptomatic patients with severe organic mitral regurgitation and preserved LV function. J Am Coll Cardiol. 2014 Oct 14;64(15):1639-40. doi: 10.1016/j.jacc.2014.07.964. No abstract available.
Related Links
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Dutch AMR study homepage
Other Identifiers
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NL39851.041.12.
Identifier Type: -
Identifier Source: org_study_id