Comparing early mitral valve repair to watchful waiting for asymptomatic patients with severe mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the outcomes of early mitral valve repair versus a conservative watchful waiting approach in asymptomatic patients diagnosed with severe organic mitral regurgitation. The study addresses the conflicting treatment strategies recommended by European and American guidelines, focusing on the potential benefits of early surgical intervention to prevent future left ventricular dysfunction. Participants will be monitored through echocardiography to assess their condition over time. The study seeks to provide clarity on the optimal management of this patient population.

Why it matters

Who can join: the full rules

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) ≥40 mm (no indexed value)

Where it's running

• Amsterdam Medical Center (AMC)
  Amsterdam, Netherlands Recruiting
• Amphia Breda
  Breda, Netherlands Recruiting
• Medisch Spectrum Twente (MST)
  Enschede, Netherlands Recruiting
• Maastricht UMC
  Maastricht, Netherlands Recruiting
• University Medical Center Utrecht (UMC Utrecht)
  Utrecht, Netherlands Recruiting
• Leiden University Medical Center (LUMC)
  Leiden, Netherlands Active not recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

  This study tests whether the SATURN TS transcatheter mitral valve replacement can be safely implanted and work well in adults with severe mitral regurgitation who are high-risk for open-heart surgery.

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• Outcomes after new edge-to-edge mitral valve repair

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• Surgical implantation of a polymer prosthetic mitral or aortic valve

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• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.