NCT06255457 Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
| NCT ID | NCT06255457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2026-03-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Study objectives: * To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery * To characterize the molecular landscape of arrhytmogenic MVP Study design: -Prospective explorative observational study Study population: -90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery
Eligibility Criteria
Inclusion criteria * Age 18 and over * Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care Exclusion criteria * Secondary mitral regurgitation * Primary mitral regurgitation not due to degenerative disease (including rheumatic disease) * Co-existing moderate or severe aortic valve disease * Congenital heart disease * Inherited or acquired cardiomyopathy * Non-incidental or symptomatic coronary artery disease * Uncontrolled atrial fibrillation (resting heart rate \> 100/min) * Pregnancy * Unable to undergo CMR