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NCT03003299NARecruiting

PARTNER 3 Trial - Aortic Valve-in-Valve

Edwards Lifesciences

Start Date

1/5/2017

Completion Date

4/1/2038

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.

Detailed Description

This is a prospective, single-arm, multicenter study.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

Edwards SAPIEN 3/SAPIEN 3 Ultra THV

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Conditions

Aortic StenosisAortic Stenosis, Severe

Locations

Banner University Medical Center

Phoenix, Arizona 85006

United States

University of California Los Angeles

Los Angeles, California 90095

United States

Sutter Medical Center

Sacramento, California 95919

United States

Kaiser Permanente San Francisco

San Francisco, California 94115

United States

Stanford University Medical Center

Stanford, California 94305

United States

UC Health Northern Colorado/Medical Center of the Rockies

Loveland, Colorado 80538

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

JFK Medical Center/ Atlantic Clinical Research Collaborative

Atlantis, Florida 33462

United States

University of Florida, Gainesville

Gainesville, Florida 32610

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Northwestern University Hospital

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Northshore University HealthSystem

Evanston, Illinois 60201

United States

Prairie Education and Research Cooperative

Springfield, Illinois 62701

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

William Beaumont Hospital

Royal Oak, Michigan 48073

United States

University of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri 64111

United States

Washington University/ Barnes-Jewish Hospital

St Louis, Missouri 63110

United States

Nebraska Heart Institute

Lincoln, Nebraska 68526

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Newark Beth Israel

Newark, New Jersey 07112

United States

University of Buffalo

Buffalo, New York 14203

United States

Winthrop University Hospital

Mineola, New York 11501

United States

New York University (NYU) Langone Medical Center

New York, New York 10016

United States

Cornell University

New York, New York 10021

United States

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York 10032

United States

Carolina's Health System

Charlotte, North Carolina 28203

United States

NC Heart and Vascular (Rex Hospital)

Raleigh, North Carolina 27607

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma 73120

United States

Providence Heart & Vascular Institute

Portland, Oregon 97225

United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania 19104

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

Baptist Memorial Hospital

Memphis, Tennessee 38120

United States

Saint Thomas Health Services

Nashville, Tennessee 37205

United States

Austin Heart, PLLC

Austin, Texas 78756

United States

Medical City Dallas Hospital

Dallas, Texas 75093

United States

The Heart Hospital Baylor Plano

Dallas, Texas 75093

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

Intermountain Medical Center

Murray, Utah 84157

United States

University of Virginia

Charlottesville, Virginia 22908

United States

Inova Heart and vascular Instritute (Fairfax Inova)

Fairfax, Virginia 22042

United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia 23507

United States

University of Wisconsin - Madison

Madison, Wisconsin 53792

United States

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia V6Z 1Y6

Canada