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Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is a new technology for use in treating aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

CMS issued a Medicare National Coverage Determination on May 1, 2012 which allows coverage of TAVR 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 trials which have been reviewed and determined to meet the requirements of coverage.

http://www.cms.gov//medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257

 

Registry Approvals

STS/ACC Transcatheter Valve Therapy (TVT) Registry
ClinicalTrials.gov number: NCT01737528
https://www.ncdr.com/TVT/Home/Default.aspx

 

Clinical Study Approvals

Study Title:  REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Randomized Clinical Evaluation
Sponsor:  Boston Scientific Corporation
ClinicalTrials.gov Number : NCT02202434
Investigational Device Exemption (IDE) Number:  G140090
CMS Approval Date: 09/13/2014

Study Title:  The Medtronic CoreValve™ Evolut R™ Clinical Study
Sponsor:  Medtronic
ClinicalTrials.gov Number: NCT01876420
Investigational Device Exemption (IDE) Number: G140059
CMS Approval Date: 07/24/2014

Study Title: TranScatheter Aortic Valve RepLacement System a US Pivotal Trial (SALUS)
Sponsor:  Direct Flow Medical, Inc.
ClinicalTrials.gov Number: NCT02163850
Investigational Device Exemption (IDE) Number: G120160/S013
CMS Approval Date: 06/05/2014

Study Title: Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO) Interventional Trial
Sponsor: St. Jude Medical
ClinicalTrials.gov Number: NCT02000115
Investigational Device Exemption (IDE) Number: G120263
CMS Approval Date: 03/25/2014

Study Title: SALUS Trial :The Direct Flow Medical Transcatherter Aortic Valve Replacement System US Feasibility Trial
Sponsor: Direct Flow Medical
ClinicalTrials.gov Number: NCT1932099
Investigational Device Exemption (IDE) Number: G120160
CMS Approval Date: 09/25/2013

Study Title: Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients with Aortic Stenosis
Sponsor: The Society of Thoracic Surgeons and The American College of Cardiology Foundation
ClinicalTrials.gov Number: NCT01787084
Investigational Device Exemption (IDE) Number: G120291
CMS Approval Date: 02/07/2013

Study Title:  Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Sponsor: Medtronic
ClinicalTrials.gov Number:  NCT01586910
Investigational Device Exemption (IDE) Number:  G120169
CMS Approval Date:  09/05/2012

Study Title: Medtronic CoreValve Expanded Use Study
Sponsor: Medtronic
ClinicalTrials.gov Number: NCT01675440
Investigational Device Exemption (IDE) Number: G100012
CMS Approval Date: 09/11/2012

Study Title:  PARTNER II Trial (Placement of AoRTic TraNscathetER Valves Trial II)
Sponsor: Edwards Lifesciences
ClinicalTrials.gov Number:  NCT01314313
Investigational Device Exemption (IDE) Number:  G090216
CMS Approval Date: 05/01/2012

Study Title: Medtronic CoreValve U.S. Pivotal Trial
Sponsor: Medtronic
ClinicalTrials.gov Number: NCT01240902
Investigational Device Exemption (IDE) Number:  G100012
CMS Approval Date: 05/01/2012

Study Title:  Medtronic CoreValve Continued Access Study
Sponsor: Medtronic
ClinicalTrials.gov Number : NCT01531374
Investigational Device Exemption (IDE) Number:  G100012
CMS Approval Date: 05/01/2012