PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

December 19, 2025 updated by: Edwards Lifesciences

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

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.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
  • Canada
      • Vancouver, Canada
        • Saint Paul's Hospital
  • Japan
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University
    • Tokyo
      • Shinjuku, Tokyo, Japan, 160-8582
        • Keio University
      • tabashi City, Tokyo, Japan, 173-8606
        • Teikyo University
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1024
        • Auckland City Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • California
      • Burlingame, California, United States, 94010
        • Mills/Peninsula Health Services
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles/Ronald Reagan Medical Center
      • Newport Beach, California, United States, 92663
        • Hoag Hospital
      • Palo Alto, California, United States, 94305
        • Stanford Hospital and Clinics
      • Sacramento, California, United States, 95816
        • Sutter Health Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente San Francisco
    • Colorado
      • Loveland, Colorado, United States, 80538
        • UC Health Northern Colorado/Medical Center of the Rockies
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Medical Center / Atlantic Clinical Research Collaborative
      • Gainesville, Florida, United States, 32610
        • University of Florida, Gainesville
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem Research Institute
      • Springfield, Illinois, United States, 62701
        • Prairie Education And Research Cooperative
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Cardiovascular Research Institute of Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • UPR - Louisiana State University Health Science Center
    • Maine
      • Auburn, Maine, United States, 04210
        • Central Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University Of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City Mid America
      • St Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital / Washington University
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Morristown Medical Center / Atlantic Health System Hospital
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel
    • New York
      • Albany, New York, United States, 12208
        • Albany
      • Buffalo, New York, United States, 14203
        • University of Buffalo
      • Mineola, New York, United States, 11501
        • Winthrop-University Hospital
      • New York, New York, United States, 10016
        • NYU Medical Center
      • New York, New York, United States, 10021
        • Cornell University
      • New York, New York, United States, 10032
        • Columbia University Medical Center/ New York Presbyterian Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolina's Health System
      • Charlotte, North Carolina, United States, 28204
        • UPR - Novant Health Heart and Vascular Institution
      • Raleigh, North Carolina, United States, 27607
        • Rex Hospital / NC Heart and Vascular Research
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital, Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43213
        • Mount Carmel Health System
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research Group
      • Tulsa, Oklahoma, United States, 74104
        • UPR-Oklahoma Heart Institute
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart & Vascular Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Health Services
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Plano, Texas, United States, 75093
        • The Heart Hosptial Baylor Plano
    • Utah
      • Salt Lake City, Utah, United States, 84157
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia
      • Falls Church, Virginia, United States, 22042
        • Fairfax INOVA
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgical aortic valve replacement (SAVR)
Procedure: SAVR
SAVR with a commercially available bioprosthetic valve.
Experimental: Transcatheter aortic valve replacement (TAVR)
Device: SAPIEN 3 THV
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
Time Frame: 1 year
Number of patients that had any of these events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Stroke
Time Frame: 30 days
Number of patients that had a stroke
30 days
New Onset Atrial Fibrillation
Time Frame: 30 days
Number of patients with this event
30 days
Length of Index Hospitalization
Time Frame: Discharge (expected average of 7 days)
Number of days from index procedure to discharge
Discharge (expected average of 7 days)
Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points
Time Frame: 30 days
Number of patients that had any of these events
30 days
Death or Stroke
Time Frame: 30 days
Number of patients that died or had a stroke
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

November 16, 2020

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimated)

February 5, 2016

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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