Transcatheter Mitral Valve Repair
Guidance for a Medicare National Coverage Determination which allows for coverage of TMVR under Coverage with Evidence Development (CED) with certain conditions.
Final
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: January 30, 2020
Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stich.
CMS issued a Medicare National Coverage Determination (NCD) on August 7, 2014 which covered transcatheter mitral valve repair (TMVR) under Coverage with Evidence Development (CED) with certain conditions. On January 19, 2021, CMS expanded coverage under CED and renamed the NCD to TEER for Mitral Valve Regurgitation to more precisely define the treatment addressed in this NCD. The complete NCD decision memos are available on our website (see links below). Under the CED criteria, CMS must approve any registry of clinical studies. Any CMS approved registry or CMS approved clinical study is listed below.
2014 TMVR Final Decision Memorandum: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=273&bc=AAgAAAAACAAA&
2021 TEER for Mitral Valve Regurgitation Final Decision Memorandum: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=297&bc=AAgAAAAACAAA&
Registry Approvals:
STS/ACC TVT Registry Mitral Module (TMVR)
Sponsor: American College of Cardiology
ClinicalTrials.gov Number: NCT02245763
CMS Approval Date: 08/07/2014
Clinical Study Approvals:
Study Title: Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)
Sponsor: Cardiothoracic Surgical Trials Network
Clinicaltrials.gov number: NCT05051033
Investigational Device Exemption (IDE) Number: G210214
CMS Approval Date: 01/04/2022
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
ClinicalTrials.gov 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
ClinicalTrials.gov 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
ClinicalTrials.gov Number: NCT01626079
Investigational Device Exemption (IDE) Number: G120024/S021
CMS Approval Date: 02/05/2015
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