PARTNER 3 Trial - Aortic Valve-in-Valve
Purpose
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
Conditions
- Aortic Stenosis
- Aortic Stenosis, Severe
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency. 2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm. 3. NYHA Functional Class ≥ II. 4. Heart Team agrees the patient is low to intermediate risk. 5. Heart Team agrees valve implantation will likely benefit the patient. 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria
- 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 moderate or severe 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 7. Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve 8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral) 9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic) 10. Anatomical characteristics that would preclude safe access to the apex (Transapical) 11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment 12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion. 13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation 14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 15. Untreated clinically significant coronary artery disease requiring revascularization 16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment 17. Emergency interventional/surgical procedures within 30 days prior to the procedure 18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure 19. Hypertrophic cardiomyopathy with obstruction 20. LVEF < 30% 21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 22. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure 23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 24. Stroke or transient ischemic attack within 90 days of enrollment 25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment 26. Renal insufficiency and/or renal replacement therapy at the time of screening 27. Active bacterial endocarditis within 180 days of the procedure 28. Patient refuses blood products 29. Estimated life expectancy < 24 months 30. Positive urine or serum pregnancy test in female subjects of childbearing potential 31. Currently participating in an investigational drug or another device study
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TAVR - Failing surgical or transcatheter valve |
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR). |
|
Recruiting Locations
Banner University Medical Center
Phoenix, Arizona 85006
Phoenix, Arizona 85006
University of California Los Angeles
Los Angeles, California 90095
Los Angeles, California 90095
Sutter Medical Center
Sacramento, California 95919
Sacramento, California 95919
Stanford University Medical Center
Stanford, California 94305
Stanford, California 94305
UC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Northwestern University Hospital
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Mayo Clinic
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri 63110
St Louis, Missouri 63110
Newark Beth Israel
Newark, New Jersey 07112
Newark, New Jersey 07112
Winthrop University Hospital
Mineola, New York 11501
Mineola, New York 11501
Cornell University
New York, New York 10021
New York, New York 10021
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York 10032
New York, New York 10032
The Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Providence Heart & Vascular Institute
Portland, Oregon 97225
Portland, Oregon 97225
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Medical City Dallas Hospital
Dallas, Texas 75093
Dallas, Texas 75093
The Heart Hospital Baylor Plano
Dallas, Texas 75093
Dallas, Texas 75093
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
Intermountain Medical Center
Murray, Utah 84157
Murray, Utah 84157
Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
Norfolk, Virginia 23507
More Details
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
Detailed Description
This is a prospective, single-arm, multicenter study.