Edwards SAPIEN 3 / SAPIEN 3 Ultra THV: Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
Study summary
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 65 years of age or older
2. Severe aortic stenosis
3. Patient is asymptomatic
4. LV ejection fraction ≥ 50%
5. Society of Thoracic Surgeons (STS) risk score ≤ 10
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. Patient is symptomatic
2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
5. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR
6. Evidence of an acute myocardial infarction ≤ 30 days before randomization
7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified
8. Severe aortic regurgitation (\>3+)
9. Severe mitral regurgitation (\>3+) or ≥ moderate mitral stenosis
10. Pre-existing mechanical or bioprosthetic valve in any position
11. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
12. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
14. Hypertrophic cardiomyopathy with obstruction
15. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy
17. Stroke or transient ischemic attack within 90 days of randomization
18. Renal insufficiency and/or renal replacement therapy
19. Active bacterial endocarditis within 180 days of randomization
20. Severe lung disease or currently on home oxygen
21. Severe pulmonary hypertension
22. History of cirrhosis or any active liver disease
23. Significant frailty as determined by the Heart Team
24. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
25. Patient refuses blood products
26. BMI \>50 kg/m2
27. Estimated life expectancy \<24 months
28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
29. Currently participating in an investigational drug or another device study.
30. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
Primary outcome measure(s)
All-cause death, all stroke, and unplanned cardiovascular hospitalization — When all patients have reached 2-year follow-up The number of patients that have any of these conditions
Trial sites (77)
Facility
City
Region
Status
Banner University Medical Center
Phoenix
Arizona
Mills Peninsula Health Services
Burlingame
California
Cedars-Sinai Medical Center
Los Angeles
California
Hoag Memorial Hospital Presbyterian
Newport Beach
California
Huntington Hospital
Pasadena
California
UC Davis Medical Center
Sacramento
California
Kaiser San Francisco Medical Center
San Francisco
California
Stanford Hospital and Clinics Palo Alto
Stanford
California
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland
Colorado
Yale University
New Haven
Connecticut
Washington Hospital Center DC
Washington D.C.
District of Columbia
The Cardiac & Vascular Institute Research Foundation
Gainesville
Florida
University of Florida
Gainesville
Florida
Piedmont Heart Institute
Atlanta
Georgia
Emory University
Atlanta
Georgia
Northwestern University
Chicago
Illinois
Rush University Medical Center Chicago
Chicago
Illinois
NorthShore University HealthSystem Research Institution
Evanston
Illinois
Alexian Brothers Hospital Network
Lisle
Illinois
Prairie Education and Research Cooperative
Springfield
Illinois
University of Iowa Hospitals and Clinics
Iowa City
Iowa
Iowa Heart Center
West Des Moines
Iowa
Cardiovascular Research Institute of Kansas
Wichita
Kansas
Ochsner Clinic Foundation
New Orleans
Louisiana
Maine Medical Center
Portland
Maine
University of Maryland Medical Center
Baltimore
Maryland
Brigham and Women's Hospital
Boston
Massachusetts
Cape Cod Hospital
Hyannis
Massachusetts
Henry Ford Hospital
Detroit
Michigan
Minneapolis Heart Institute
Minneapolis
Minnesota
University of Minnesota Medical Center
Minneapolis
Minnesota
Mayo Clinic
Rochester
Minnesota
CentraCare Heart
Saint Cloud
Minnesota
Saint Luke's Hospital of Kansas City Mid America
Kansas City
Missouri
St. Patrick Hospital
Missoula
Montana
Mary Hitchcock Memorial Hospital
Lebanon
New Hampshire
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown
New Jersey
Newark Beth Israel Medical Center
Newark
New Jersey
Rutgers Robert Wood Johnson Medical School
Piscataway
New Jersey
Albany Medical College
Albany
New York
+ 37 more sites — see the full list on the official registry below.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.