Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2017-01-05
2038-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAVR - Failing surgical or transcatheter valve
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Interventions
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Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Eligibility Criteria
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Inclusion Criteria
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
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
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Chris S Malaisrie, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Alan Zajarias, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Mayra Guerrero, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Banner University Medical Center
Phoenix, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
Sutter Medical Center
Sacramento, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
UC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
JFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis, Florida, United States
University of Florida, Gainesville
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University HealthSystem
Evanston, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Newark Beth Israel
Newark, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
Winthrop University Hospital
Mineola, New York, United States
New York University (NYU) Langone Medical Center
New York, New York, United States
Cornell University
New York, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States
Carolina's Health System
Charlotte, North Carolina, United States
NC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Saint Thomas Health Services
Nashville, Tennessee, United States
Austin Heart, PLLC
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
The Heart Hospital Baylor Plano
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Heart and vascular Instritute (Fairfax Inova)
Fairfax, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Other Identifiers
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2015-08 AVIV
Identifier Type: -
Identifier Source: org_study_id
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