Transcatheter Mitral Valve Repair

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.

Decision Memo

Registry Approvals:

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

Clinical Study Approvals:

Study Title: Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy MItral Regurgitation who are Candidates for Surgery (REPAIR-MR)  
Sponsor: Abbott Number: NCT04198870 
Investigational Device Exemption (IDE) Number: G190212
CMS Approval Date: 07/17/2020

Study Title: Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID) Pivotal Trial
Sponsor: Edwards Lifesciences Number: NCT03706833
Investigational Device Exemption (IDE) Number: G170166
CMS Approval Date: 11/19/2018

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

Page Last Modified:
08/11/2020 06:19 AM