Transcatheter Mitral Valve Repair (TMVR)

Transcatheter mitral valve repair (TMVR) is a procedure used to treat mitral regurgitation which is the most common type of heart valve insufficiency in the country. 

CMS issued a Medicare National Coverage Determination on August 7, 2014 which allows for coverage of TMVR under Coverage with Evidence Development (CED) with certain conditions.  The complete determination is available on our website.  As part of CED, we are identifying below the Medicare approved registry and Medicare approved clinical trial which have been reviewed and determined to meet the requirements of coverage.

Clinical Study Approvals:

Study Title:  Cardiovascular Outcomes Assessment of the MitraClip® Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (the COAPT trial)
Sponsor:  Abbott Vascular Number:  NCT01626079
Investigational Device Exemption (IDE) Number:  G120024/S021
CMS Approval Date: 02/05/2015

Study Title: STS/ACC TVT Registry Mitral Module (TMVR)
Sponsor: American College of Cardiology Number:  NCT02245763
CMS Approval Date: 08/07/2014