PRIMARY Ancillary Substudy

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.

NCT Number	NCT07103733
Lead Sponsor	Annetine Gelijns Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Mitral Valve Prolapse, Left Ventricular Fibrosis, Ventricular Arrhythmias
Enrollment	250 participants
Start Date	2023-10-16
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-19