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Primary Diagnosis

Previous Mitral Valve Replacement

​​​​​Study Purpose

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic (tissue) valve who are an intermediate surgical risk.

Principal Investigators: Robert L. Smith, II, MD / Molly Szerlip, MD

​Trial Details

Locations: Baylor Scott & White The Heart Hospital – Plano

Sponsor: Edwards

IRB Number: 017-468

Trial Status: Enrolling

Exclusions: Adults only

Change in Care: 

Contact Information:

Necole Kell, RN

Brittany Zingler, RN

Full Protocol Title

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement who have Severe, Calcific, Symptomatic Aortic Stenosis

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