Edwards SAPIEN 3/SAPIEN 3 Ultra THV: Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
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 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:
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 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
Primary outcome measure(s)
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke — 1 year Number of patients that died and/or had a stroke
Trial sites (51)
Facility
City
Region
Status
Banner University Medical Center
Phoenix
Arizona
Recruiting
University of California Los Angeles
Los Angeles
California
Recruiting
Sutter Medical Center
Sacramento
California
Recruiting
Kaiser Permanente San Francisco
San Francisco
California
Withdrawn
Stanford University Medical Center
Stanford
California
Recruiting
UC Health Northern Colorado/Medical Center of the Rockies
Loveland
Colorado
Recruiting
Hartford Hospital
Hartford
Connecticut
Recruiting
JFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis
Florida
Withdrawn
University of Florida, Gainesville
Gainesville
Florida
Withdrawn
Emory University Hospital
Atlanta
Georgia
Recruiting
Northwestern University Hospital
Chicago
Illinois
Recruiting
Rush University Medical Center
Chicago
Illinois
Recruiting
Northshore University HealthSystem
Evanston
Illinois
Withdrawn
Prairie Education and Research Cooperative
Springfield
Illinois
Withdrawn
Ochsner Clinic Foundation
New Orleans
Louisiana
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
Henry Ford Hospital
Detroit
Michigan
Recruiting
William Beaumont Hospital
Royal Oak
Michigan
Withdrawn
University of Minnesota Medical Center
Minneapolis
Minnesota
Withdrawn
Mayo Clinic
Rochester
Minnesota
Recruiting
Saint Luke's Hospital of Kansas City Mid America
Kansas City
Missouri
Withdrawn
Washington University/ Barnes-Jewish Hospital
St Louis
Missouri
Recruiting
Nebraska Heart Institute
Lincoln
Nebraska
Withdrawn
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
Withdrawn
Newark Beth Israel
Newark
New Jersey
Recruiting
University of Buffalo
Buffalo
New York
Withdrawn
Winthrop University Hospital
Mineola
New York
Recruiting
New York University (NYU) Langone Medical Center
New York
New York
Withdrawn
Cornell University
New York
New York
Recruiting
Columbia University Medical Center/ New York Presbyterian Hospital
New York
New York
Recruiting
Carolina's Health System
Charlotte
North Carolina
Withdrawn
NC Heart and Vascular (Rex Hospital)
Raleigh
North Carolina
Withdrawn
The Christ Hospital
Cincinnati
Ohio
Recruiting
The Cleveland Clinic Foundation
Cleveland
Ohio
Recruiting
Oklahoma Cardiovascular Research Group
Oklahoma City
Oklahoma
Withdrawn
Providence Heart & Vascular Institute
Portland
Oregon
Recruiting
University of Pennsylvania Hospital
Philadelphia
Pennsylvania
Recruiting
Allegheny General Hospital
Pittsburgh
Pennsylvania
Recruiting
Lankenau Medical Center
Wynnewood
Pennsylvania
Recruiting
Baptist Memorial Hospital
Memphis
Tennessee
Withdrawn
+ 11 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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