The PARTNER 3 - AVIV Trial

Purpose

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.

Conditions

  • Aortic Stenosis
  • Cardiomyopathy, Hypertrophic

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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.

Exclusion Criteria

  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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Failing surgical valve
Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
  • Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
    Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
    Other names:
    • TAVI
Experimental
Failing transcatheter valve
Patients with a failing transcatheter bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
  • Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
    Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
    Other names:
    • TAVI

Recruiting Locations

More Details

NCT ID
NCT03003299
Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

Justine Encabo
949-250-3502
Justine_Encabo@edwards.com

Detailed Description

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.