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.

Contact Information

Deanna Aubry

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.

Study Details

Clinical Trial Investigator

Clifford J. Kavinsky, MD, PhD

Contact Information

Deanna Aubry

(312) 942-9398

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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