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

NCT02675114 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 2015-08
• Study Type: interventional
• Target: 1,000
• Locations: 5 countries
• Sites: 77

Brief 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.

Conditions

Aortic Stenosis

Keywords

SAPIEN 3; cardiovascular disease; heart disease; aortic stenosis; Surgical aortic valve replacement (SAVR); Transcatheter aortic valve replacement (TAVR)

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)

  Number of patients that had any of these events

  1 year

Secondary Outcomes (5)

• New Onset Atrial Fibrillation

  30 days

• Length of Index Hospitalization

  Discharge (expected average of 7 days)

• Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points

  30 days

• Death or Stroke

  30 days

• All Stroke

  30 days

Study Arms (2)

Surgical aortic valve replacement (SAVR)

ACTIVE COMPARATOR

Procedure: SAVR

Transcatheter aortic valve replacement (TAVR)

EXPERIMENTAL

Device: SAPIEN 3 THV

Interventions

SAVR PROCEDURE

SAVR with a commercially available bioprosthetic valve.

Surgical aortic valve replacement (SAVR)

SAPIEN 3 THV DEVICE

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

Transcatheter aortic valve replacement (TAVR)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe, calcific aortic stenosis
• 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%
• Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score \< 4
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

• Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
• Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
• Evidence of an acute myocardial infarction ≤ 30 days before randomization
• Aortic valve is unicuspid, bicuspid, or non-calcified
• Severe aortic regurgitation (\>3+)
• Severe mitral regurgitation (\>3+) ≥ moderate stenosis
• Pre-existing mechanical or bioprosthetic valve in any position
• Complex coronary artery disease:
• Unprotected left main coronary artery
• Syntax score \> 32
• Heart Team assessment that optimal revascularization cannot be performed
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
• Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
• Hypertrophic cardiomyopathy with obstruction

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (77)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Mills/Peninsula Health Services

Burlingame, California, 94010, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles/Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

Sutter Health Sacramento

Sacramento, California, 95816, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94115, United States

Location

UC Health Northern Colorado/Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Hartford

Hartford, Connecticut, 06102, United States

Location

JFK Medical Center / Atlantic Clinical Research Collaborative

Atlantis, Florida, 33462, United States

Location

University of Florida, Gainesville

Gainesville, Florida, 32610, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University HealthSystem Research Institute

Evanston, Illinois, 60201, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

UPR - Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Central Maine Medical Center

Auburn, Maine, 04210, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri, 64111, United States

Location

Barnes-Jewish Hospital / Washington University

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Morristown Medical Center / Atlantic Health System Hospital

Morristown, New Jersey, 07962, United States

Location

Newark Beth Israel

Newark, New Jersey, 07112, United States

Location

Albany

Albany, New York, 12208, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Winthrop-University Hospital

Mineola, New York, 11501, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

Cornell University

New York, New York, 10021, United States

Location

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Carolina's Health System

Charlotte, North Carolina, 28203, United States

Location

UPR - Novant Health Heart and Vascular Institution

Charlotte, North Carolina, 28204, United States

Location

Rex Hospital / NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

The Christ Hospital, Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

UPR-Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Saint Thomas Health Services

Nashville, Tennessee, 37205, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The Heart Hosptial Baylor Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84157, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Fairfax INOVA

Falls Church, Virginia, 22042, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Saint Paul's Hospital

Vancouver, Canada

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan

Location

Osaka University

Suita, Osaka, 565-0871, Japan

Location

Keio University

Shinjuku, Tokyo, 160-8582, Japan

Location

Teikyo University

tabashi City, Tokyo, 173-8606, Japan

Location

Auckland City Hospital

Grafton, Auckland, 1024, New Zealand

Location

Related Publications (12)

• 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. 2026 Feb 19;394(8):773-783. doi: 10.1056/NEJMoa2509766. Epub 2025 Oct 27.

  PMID: 41144631 DERIVED

• 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.

  PMID: 40243974 DERIVED

• 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.

  PMID: 37874020 DERIVED

• 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.

  PMID: 36813373 DERIVED

• 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.

  PMID: 36622552 DERIVED

• 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.

  PMID: 35595203 DERIVED

• 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.

  PMID: 34139864 DERIVED

• 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.

  PMID: 34130476 DERIVED

• 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.

  PMID: 33663731 DERIVED

• 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.

  PMID: 32272848 DERIVED

• 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.

  PMID: 30883058 DERIVED

• 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.

  PMID: 28279376 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Research Director
• Organization: Edwards Lifesciences

THV_CT.gov@Edwards.com

949-250-2500

Study Officials

• Martin B Leon, MD, FACC

  Columbia University Medical Center/ New York Presbyterian Hospital, NY

  PRINCIPAL INVESTIGATOR

• Michael J Mack, MD, FACC

  The Heart Hospital Baylor Plano, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 5, 2016
• Study Start: March 1, 2016
• Primary Completion: November 16, 2020
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 14, 2026
• Results First Posted: December 2, 2021

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5); CA (1); AU (2); NZ (1); US (68)