PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
NCT ID: NCT02675114
Last Updated: 2026-01-14
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
1000 participants
INTERVENTIONAL
2016-03-31
2029-12-31
Brief Summary
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Detailed Description
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A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgical aortic valve replacement (SAVR)
SAVR
SAVR with a commercially available bioprosthetic valve.
Transcatheter aortic valve replacement (TAVR)
SAPIEN 3 THV
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Interventions
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SAVR
SAVR with a commercially available bioprosthetic valve.
SAPIEN 3 THV
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Martin B Leon, MD, FACC
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center/ New York Presbyterian Hospital, NY
Michael J Mack, MD, FACC
Role: PRINCIPAL_INVESTIGATOR
The Heart Hospital Baylor Plano, TX
Locations
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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
Countries
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References
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Leon MB, Mack MJ, Pibarot P, Hahn RT, Thourani VH, Kodali SH, Genereux P, Kapadia SR, Cohen DJ, Pocock SJ, Zhang Y, Szerlip M, Ternacle J, Malaisrie SC, Herrmann HC, Szeto WY, Russo MJ, Babaliaros V, Nazif T, Webb JG, Makkar RR; PARTNER 3 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2025 Oct 27. doi: 10.1056/NEJMoa2509766. Online ahead of print.
Hahn RT, Ternacle J, Silva I, Giuliani C, Zanuttini A, Theron A, Cristell N, Bernier M, Skaf S, Beaudoin J, Kodali SK, Russo M, Kapadia SR, Malaisrie CS, Cohen DJ, Leipsic J, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Park B, Gunnarsson M, Webb JG, Smith CR, Makkar R, Thourani VH, Mack MJ, Leon MB, Pibarot P; PARTNER 3 Investigators. 5-Year Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. JACC Cardiovasc Imaging. 2025 Jun;18(6):625-640. doi: 10.1016/j.jcmg.2025.01.015. Epub 2025 Apr 16.
Mack MJ, Leon MB, Thourani VH, Pibarot P, Hahn RT, Genereux P, Kodali SK, Kapadia SR, Cohen DJ, Pocock SJ, Lu M, White R, Szerlip M, Ternacle J, Malaisrie SC, Herrmann HC, Szeto WY, Russo MJ, Babaliaros V, Smith CR, Blanke P, Webb JG, Makkar R; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023 Nov 23;389(21):1949-1960. doi: 10.1056/NEJMoa2307447. Epub 2023 Oct 24.
Genereux P, Cohen DJ, Pibarot P, Redfors B, Bax JJ, Zhao Y, Prince H, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Arnold SV. Cardiac Damage and Quality of Life After Aortic Valve Replacement in the PARTNER Trials. J Am Coll Cardiol. 2023 Feb 28;81(8):743-752. doi: 10.1016/j.jacc.2022.11.059.
Kuck KH, Leidl R, Frankenstein L, Wahlers T, Sarmah A, Candolfi P, Shore J, Green M. Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk. Adv Ther. 2023 Mar;40(3):1031-1046. doi: 10.1007/s12325-022-02392-y. Epub 2023 Jan 9.
Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
Ternacle J, Al-Azizi K, Szerlip M, Potluri S, Hamandi M, Blanke P, Leipsic J, Dahou A, Salaun E, Vincent F, Rogers E, Alu MC, Lu M, Yu X, Thourani VH, Hahn RT, Leon MB, Pibarot P, Mack MJ. Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e010336. doi: 10.1161/CIRCINTERVENTIONS.120.010336. Epub 2021 Jun 18.
Herrmann HC, Cohen DJ, Hahn RT, Babaliaros VC, Yu X, Makkar R, McCabe J, Szerlip M, Kapadia S, Russo M, Malaisrie SC, Webb JG, Szeto WY, Kodali S, Thourani VH, Mack MJ, Leon MB. Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2021 Jul;14(7):e010310. doi: 10.1161/CIRCINTERVENTIONS.120.010310. Epub 2021 Jun 16.
Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Blanke P, Leipsic JA, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Herrmann HC, Szeto WY, Genereux P, Pershad A, Lu M, Webb JG, Smith CR, Pibarot P; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar 9;77(9):1149-1161. doi: 10.1016/j.jacc.2020.12.052.
Pibarot P, Salaun E, Dahou A, Avenatti E, Guzzetti E, Annabi MS, Toubal O, Bernier M, Beaudoin J, Ong G, Ternacle J, Krapf L, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Leipsic J, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Alu MC, Xu K, Rogers E, Webb JG, Smith CR, Mack MJ, Leon MB, Hahn RT; PARTNER 3 Investigators. Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial. Circulation. 2020 May 12;141(19):1527-1537. doi: 10.1161/CIRCULATIONAHA.119.044574. Epub 2020 Apr 10.
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-08
Identifier Type: -
Identifier Source: org_study_id
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