Summary

for people ages 19 years and up (full criteria)
at UCLA
study started
estimated completion

Description

Summary

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

Official Title

P3-AVIV is a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN 3 THV in Patients With a Failing Aortic Bioprosthetic Valve

Details

A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency.

Keywords

Aortic Stenosis Cardiomyopathy, Hypertrophic Sapien 3 Partner 3 cardiovascular disease heart disease SAVR TAVR failing surgical valve failing bioprosthetic valve failing valve Cardiomyopathies Aortic Valve Stenosis Edwards SAPIEN 3 transcatheter valve, Model 9600TFX Failing transcatheter valve

Eligibility

You can join if…

Open to people ages 19 years and up

  1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
  3. NYHA Functional Class ≥ II.
  4. Heart Team agrees valve implantation will likely benefit the patient.
  5. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

You CAN'T join if...

  1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
  2. Severe regurgitation (>3+) or stenosis of any other valve.
  3. Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
  4. Failing valve is unstable, rocking, or not structurally intact.
  5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  6. Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
  7. Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Kaiser Permanente San Francisco accepting new patients
    San Francisco California 94115 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03003299
Study Type
Interventional
Last Updated