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&fromdb=true

Registry Approvals

STS/ACC Transcatheter Valve Therapy (TVT) Registry

https://www.ncdr.com/TVT/Home/Default.aspx

Clinical Study Approvals

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 CoreValue U.S. Pivotal Trial

Sponsor: Medtronic

ClinicalTrials.gov Number: NCT01240902

Investigational Device Exemption (IDE) Number:  G100012

CMS Approval Date: 5/1/2012  

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

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