The REPLICATE Registry
Research type
Research Study
Full title
Beating Heart Mitral Valve Repair with the HARPOON™ System: Real world outcomes from a multicenter observational European registry (REPLICATE)
IRAS ID
296970
Contact name
Reuben Jeganathan
Contact email
Sponsor organisation
HARPOON Medical, an indirect wholly-owned subsidiary of Edwards Lifesciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 20 days
Research summary
Mitral valve disease is the second most common valvular heart disorder requiring surgery in Europe, with nearly 8 million Europeans estimated to have severe mitral valve regurgitation (MR) (AGENAS, 2015).
The HARPOON™ System - a beating Heart Mitral Valve Repair System - is intended to reduce the degree of mitral regurgitation in patients with severe mitral regurgitation caused by mid-segment posterior leaflet prolapse as a result of degenerative mitral valve disease by delivering and anchoring ePTFE chords to the prolapsed mitral valve leaflet in a beating heart.
This registry will collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
150 patients in up to 50 research centers in Europe will be treated in this single-arm, prospective, multicenter, post market observational study. Patients treated with the Harpoon™ System will be followed-up at discharge, 30 days, 1-year and annually thereafter through 5 years post-implant, as per local standard of care.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0211
Date of REC Opinion
27 Sep 2021
REC opinion
Unfavourable Opinion