Early mitral valve repair versus watchful waiting in asymptomatic patients with severe organic mitral regurgitation; a multicenter, randomised trial.

Completed

• Conditions: leaking heart valve; mitral valve regurgitation; 10046973

• Registration Number: NL-OMON41282
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

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 mitral regurgitation as issued by the ESC guidelines. For practical reasons, referring cardiologists can use a ESC guidelines based index that was validated in our 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.
- 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 advanve, 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified