NL-OMON41282
Completed
N/A
Early mitral valve repair versus watchful waiting in asymptomatic patients with severe organic mitral regurgitation; a multicenter, randomised trial. - Dutch AMR
niversitair Medisch Centrum Utrecht0 sites250 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- leaking heart valve
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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