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Study of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Aortic Bioprosthetic Valve

Clinical Trial Title: 
PARTNER 3 AVIV: A prospective, single-arm, multicenter study to investigate the safety and effectiveness of SAPIEN 3 transcatheter heart valve implantation in patients with a failing aortic bioprosthetic valve.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Clifford J. Kavinsky, MD, PhD
Clinical Trial Protocol Description: 

The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing transcatheter aortic bioprosthetic valve.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have failing transcatheter aortic bioprosthetic valve with ≥ moderate stenosis and/or ≥ moderate insufficiency.
  • Have bioprosthetic valve with an internal orifice diameter of 16mm to 27mm.
  • Have NYHA Functional Class ≥ II.

You will be excluded from the study if any of the following criteria apply to you:

  • Have any paravalvular leak (PVL) in the aortic bioprosthetic valve.
  • Need any concomitant revascularization for coronary artery disease (CAD).
  • Have EF < 30% and eGFR < 30.
  • Have severe regurgitation (>3+) or stenosis of any other valve.

This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided.

Clinical Trial Area: 
Heart and Vascular Conditions
Contact Phone: 
(312) 942-9398
Contact Name: 
Deanna Aubry