leaking heart valve mitral valve regurgitation
Conditions
Interventions
Intervention will be early MV repair compared to a watchful waiting strategy.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be calculated as *time to first event*. The primary outcome measures the composite endpoint of: - cardiovascular mortality; - congestive heart failure*; - non-fatal cardiovascular events requiring hospitalization, defined as: stroke/cerebrovascular accident (CVA), atrial fibrillation* (permanent or requiring hospitalization) and/or reoperation after elective MV surgery. * the occurrence of: - congestive heart failure or atrial fibrillation in the watchful waiting arm resulting in a class I or class IIa indication for elective MV surgery; and - post-operative congestive heart failure or atrial fibrillation or reoperation within 30 days after elective MV surgery (likely to be related to MV surgery and not directly life threatening) will not be considered as an endpoint. Death is cardiovascular mortality, unless you can prove there is another cause for death. Congestive heart failure is the clinical diagnosis of heart failure and/or requiring diuretics medication. According to the World Health Organisation (WHO) definition, we explain stroke by "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin". Permanent atrial fibrillation (AF) is defined as AF present for >24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 'Key secondary outcome' inlcudes the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events. divided in the endpoints: stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV repair. A detailed description of the components *cardiovascular mortality*, *congestive heart failure* and hospitalization for nonfatal cardiovascular events* is given in the definition of the primary outcome. - 'Explorative secondary outcome' measures the outcome of the separate components: incidence of all-cause mortality, incidence of myocardial infarction, incidence of pacemaker implantation, incidence of transient ischemic attack (TIA), incidence of pulmonary embolism, total direct and indirect costs, cost-effectiveness, health-related quality of life, echocardiographic and cardiac magnetic resonance (CMR) parameters, exercise test parameters, paroxysmal atrial fibrillation (AF present for | — |
Countries
Netherlands
Outcome results
None listed