Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

NCT Number	NCT05051033
Lead Sponsor	Annetine Gelijns Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Mitral Valve Regurgitation
Enrollment	450 participants
Start Date	2022-02-21
Primary Completion	2028-11-15 (estimated)
Study Completion	2030-11-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-24