| NCT ID | NCT07103733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Annetine Gelijns |
| Condition | Mitral Valve Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2027-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.
Eligibility Criteria
Inclusion Criteria: * Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial. * For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial. Exclusion Criteria: * Severe claustrophobia not controlled with sedation. * Prior adverse reaction to gadolinium administration. * Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging. * Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).