Medtronic CoreValve? U.S. Pivotal Trial (2011-2017)

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Funded by National Institutes of Health

Funding Years: 2011-2017

The CoreValve US Pivotal Trial applies clinical best practices—including CT-based sizing—and is meticulously monitored, including the use of an independent echocardiographic core lab. Within the trial, the High Risk Study randomized 795 patients between surgical aortic valve replacement (SAVR) and Transcatheter Aortic Valve Implantation (TAVI) with the CoreValve System across 45 US sites. The TAVI procedure is used as an alternative to open heart surgery and allows access to the diseased aortic valve via an artery in the leg and is designed for patients with severe aortic stenosis who are at high risk for surgery due to age or other health issues.

PI(s): David Bach, G M Deeb

Co-I(s): Devin Brown, Stanley Chetcuti, Paul Grossman, Himanshu Patel, Michael Shea, Darin Zahuranec