Current Clinical Trials for Transcatheter Mitral Valve Repair

ACTIVE: Edwards Cardioband System Pivotal Clinical Trial

This trial seeks to establish the safety and effectiveness of the Edwards Cardioband System in patients with clinically significant functional mitral regurgitation. Patients will be randomized to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline-directed medical therapy (GDMT) or GDMT alone.

NewYork-Presbyterian/Columbia
Principal Investigator
Martin B. Leon, MD | [email protected]

APOLLO: TMVR with the Medtronic Intrepid™ System

This multicenter, global pre-market trial will evaluate patients with severe symptomatic mitral regurgitation in two subject groups: The randomized group will be randomized on a 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device. Subjects will be seen at pre- and post-procedure, discharge, 30 days, six months, and annually through five years.

NewYork-Presbyterian/Columbia
Principal Investigators
Vinayak N. Bapat, MD | [email protected]
Martin B. Leon, MD | [email protected]

CEASE-MR: TMVR with the Tendyne System

This pivotal study is looking at the performance of the Tendyne Mitral Valve Transcatheter System. The study includes adult patients with symptomatic mitral regurgitation, as well as degenerative and functional disease. Patients will be randomized against standard surgical intervention. Follow-up evaluations will be conducted through two years post-implantation.

NewYork-Presbyterian/Columbia
Principal Investigator
Arash Salemi, MD | [email protected]

MITRAL: Mitral Implantation of TRAnscatheter vaLves

The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™ and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.

NewYork-Presbyterian/Columbia
Principal Investigators
Martin B. Leon, MD | [email protected]
Susheel K. Kodali, MD | [email protected]

ReChord: Neochord DS1000 System Versus Open Surgical Repair

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

NewYork-Presbyterian/Columbia
Principal Investigator
Isaac George, MD | [email protected]