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
- Page last Modified: 09/12/2012 12:29 PM
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