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ACTIVE NOT RECRUITING

NCT02675114

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

Summary

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Official title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2016-03

Completion Date

2029-12

Last Updated

2026-01-14

Healthy Volunteers

Conditions

Aortic Stenosis

Interventions

PROCEDURE

SAVR

SAVR with a commercially available bioprosthetic valve.

DEVICE

SAPIEN 3 THV

TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System

Inclusion Criteria: 1. Severe, calcific aortic stenosis 2. New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) \<50% 3. Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score \< 4 4. 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. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve 2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath 3. Evidence of an acute myocardial infarction ≤ 30 days before randomization 4. Aortic valve is unicuspid, bicuspid, or non-calcified 5. Severe aortic regurgitation (\>3+) 6. Severe mitral regurgitation (\>3+) ≥ moderate stenosis 7. Pre-existing mechanical or bioprosthetic valve in any position 8. Complex coronary artery disease: 1. Unprotected left main coronary artery 2. Syntax score \> 32 3. Heart Team assessment that optimal revascularization cannot be performed 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization 10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states 11. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization 12. Hypertrophic cardiomyopathy with obstruction 13. Ventricular dysfunction with LVEF \< 30% 14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 15. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure 16. Stroke or transient ischemic attack within 90 days of randomization 17. Renal insufficiency and/or renal replacement therapy at the time of screening. 18. Active bacterial endocarditis within 180 days of randomization 19. Severe lung disease or currently on home oxygen 20. Severe pulmonary hypertension 21. History of cirrhosis or any active liver disease 22. Significant frailty as determined by the Heart Team 23. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement 24. Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation 25. Patient refuses blood products 26. Body mass index \> 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. Immobility that would prevent completion of study procedures 30. Patient is not a candidate for both arms of the study 31. Currently participating in an investigational drug or another device study.

Locations (77)

University of Alabama

Birmingham, Alabama, United States

Banner University Medical Center

Phoenix, Arizona, United States

Mills/Peninsula Health Services

Burlingame, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles/Ronald Reagan Medical Center

Los Angeles, California, United States

Hoag Hospital

Newport Beach, California, United States

Stanford Hospital and Clinics

Palo Alto, California, United States

Sutter Health Sacramento

Sacramento, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

UC Health Northern Colorado/Medical Center of the Rockies

Loveland, Colorado, United States

Hartford

Hartford, Connecticut, United States

JFK Medical Center / Atlantic Clinical Research Collaborative

Atlantis, Florida, United States

University of Florida, Gainesville

Gainesville, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Florida Hospital

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

NorthShore University HealthSystem Research Institute

Evanston, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

UPR - Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Central Maine Medical Center

Auburn, Maine, 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

Barnes-Jewish Hospital / Washington University

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Morristown Medical Center / Atlantic Health System Hospital

Morristown, New Jersey, United States

Newark Beth Israel

Newark, New Jersey, United States

Albany

Albany, New York, United States

University of Buffalo

Buffalo, New York, United States

Winthrop-University Hospital

Mineola, New York, United States

NYU 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

UPR - Novant Health Heart and Vascular Institution

Charlotte, North Carolina, United States

Rex Hospital / NC Heart and Vascular Research

Raleigh, North Carolina, United States

The Christ Hospital, Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Mount Carmel Health System

Columbus, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

UPR-Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Providence Heart & Vascular Institute

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Saint Thomas Health Services

Nashville, Tennessee, United States

Austin Heart

Austin, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

The Heart Hosptial Baylor Plano

Plano, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Fairfax INOVA

Falls Church, Virginia, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Saint Paul's Hospital

Vancouver, Canada

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Osaka University

Suita, Osaka, Japan

Keio University

Shinjuku, Tokyo, Japan

Teikyo University

tabashi City, Tokyo, Japan

Auckland City Hospital

Grafton, Auckland, New Zealand

Clinical Research Directory

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (77)