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 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•- 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.

•- 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

发起方

niversitair Medisch Centrum Utrecht