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Active, not recruitingNo phase

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

Key facts

Who runs it
Edwards Lifesciences
Where
Albany, Atlanta, Atlantis, Auburn, Austin, Birmingham, Boston, Buffalo, Burlingame, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Detroit, Evanston, Falls Church, Gainesville, Hartford, Honolulu, Houston, Iowa City, Kansas City, Lebanon, Lincoln, Los Angeles, Loveland, Madison, Memphis, Miami Beach, Mineola, Minneapolis, Morristown, Nashville, New Orleans, New York, Newark, Newport Beach, Norfolk, Oklahoma City, Orlando, Palo Alto, Philadelphia, Phoenix, Pittsburgh, Plano, Portland, Raleigh, Rochester, Royal Oak, Sacramento, Salt Lake City, San Francisco, Seattle, Springfield, St Louis, Tulsa, Wichita, Wynnewood, and York, United StatesSee the 68 sitesAlso in 4 other countries, 9 sites
Trial code
Status
Active, not recruiting
People taking part
1,000 people enrolled
Started
Mar 2016
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • SAVR
  • SAPIEN 3 THV
Record updated
14 January 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Evidence of an acute myocardial infarction ≤ 30 days before randomization
  • Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  • Severe lung disease or currently on home oxygen
  • Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
  • Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
  • Currently participating in an investigational drug or another device study
  • Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
  • 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
  • Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  • Stroke or transient ischemic attack within 90 days of randomization
  • Renal insufficiency and/or renal replacement therapy at the time of screening
  • Severe pulmonary hypertension
  • History of cirrhosis or any active liver disease
  • Significant frailty as determined by the Heart Team
  • Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement
  • Ventricular dysfunction with LVEF < 30%
  • Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
  • 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
  • Hypertrophic cardiomyopathy with obstruction
  • Active bacterial endocarditis within 180 days of randomization
  • Patient refuses blood products
  • Body mass index > 50 kg/m2
  • Estimated life expectancy < 24 months
  • Immobility that would prevent completion of study procedures
  • Patient is not a candidate for both arms of the study

Where in United States

Also in 4 other countries, 9 sites

  • AlbanyAlbany, United StatesNo longer taking part
  • Emory UniversityAtlanta, United StatesNo longer taking part
  • JFK Medical Center/ Atlantic Clinical Research CollaborativeAtlantis, United StatesNo longer taking part
  • Central Maine Medical CenterAuburn, United StatesNo longer taking part
  • Austin HeartAustin, United StatesNo longer taking part
  • University of AlabamaBirmingham, United StatesNo longer taking part
  • Brigham and Women's HospitalBoston, United StatesNo longer taking part
  • University of BuffaloBuffalo, United StatesNo longer taking part
  • Mills Peninsula Health ServicesBurlingame, United StatesNo longer taking part
  • Carolina's Health SystemCharlotte, United StatesNo longer taking part
  • UPR - Novant Health Heart and Vascular InstitutionCharlotte, United StatesNo longer taking part
  • University of VirginiaCharlottesville, United StatesNo longer taking part
  • Northwestern UniversityChicago, United StatesNo longer taking part
  • Rush University Medical CenterChicago, United StatesNo longer taking part
  • The Christ Hospital- CincinnatiCincinnati, United StatesNo longer taking part
  • Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
  • Mount Carmel Health SystemColumbus, United StatesNo longer taking part
  • Medical City Dallas HospitalDallas, United StatesNo longer taking part
  • Henry Ford HospitalDetroit, United StatesNo longer taking part
  • NorthShore University HealthSystem Research InstituteEvanston, United StatesNo longer taking part
  • Fairfax INOVAFalls Church, United StatesNo longer taking part
  • University of Florida - GainesvilleGainesville, United StatesNo longer taking part
  • HartfordHartford, United StatesNo longer taking part
  • The Queen's Medical CenterHonolulu, United StatesNo longer taking part
  • The University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
  • University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
  • Saint Luke's Hospital of Kansas City Mid AmericaKansas City, United StatesNo longer taking part
  • Dartmouth Hitchcock Medical CenterLebanon, United StatesNo longer taking part
  • Nebraska Heart InstituteLincoln, United StatesNo longer taking part
  • Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
  • University of California Los Angeles - Ronald Reagan Medical CenterLos Angeles, United StatesNo longer taking part
  • UC Health Northern Colorado (Medical Center of the Rockies)Loveland, United StatesNo longer taking part
  • University of WisconsinMadison, United StatesNo longer taking part
  • Baptist Memorial HospitalMemphis, United StatesNo longer taking part
  • Mount Sinai Medical CenterMiami Beach, United StatesNo longer taking part
  • Winthrop University HospitalMineola, United StatesNo longer taking part
  • University of Minnesota Medical CenterMinneapolis, United StatesNo longer taking part
  • Morristown Medical Center / Atlantic Health System HospitalMorristown, United StatesNo longer taking part
  • Saint Thomas Health ServicesNashville, United StatesNo longer taking part
  • Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
  • UPR - Louisiana State University Health Science CenterNew Orleans, United StatesNo longer taking part
  • Columbia University Medical Center/New York-Presbyterian HospitalNew York, United StatesNo longer taking part
  • Cornell UniversityNew York, United StatesNo longer taking part
  • NYU Medical CenterNew York, United StatesNo longer taking part
  • Newark Beth IsraelNewark, United StatesNo longer taking part
  • Hoag HospitalNewport Beach, United StatesNo longer taking part
  • Sentara Cardiovascular Research InstituteNorfolk, United StatesNo longer taking part
  • Oklahoma Cardiovascular Research GroupOklahoma City, United StatesNo longer taking part
  • Florida HospitalOrlando, United StatesNo longer taking part
  • Stanford Hospital and ClinicsPalo Alto, United StatesNo longer taking part
  • University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
  • Banner University Medical CenterPhoenix, United StatesNo longer taking part
  • Allegheny General HospitalPittsburgh, United StatesNo longer taking part
  • The Heart Hosptial Baylor PlanoPlano, United StatesNo longer taking part
  • Providence Heart & Vascular InstitutePortland, United StatesNo longer taking part
  • Rex Hospital / NC Heart and Vascular ResearchRaleigh, United StatesNo longer taking part
  • Mayo ClinicRochester, United StatesNo longer taking part
  • William Beaumont HospitalRoyal Oak, United StatesNo longer taking part
  • Sutter Health SacramentoSacramento, United StatesNo longer taking part
  • Intermountain Medical CenterSalt Lake City, United StatesNo longer taking part
  • Kaiser Permanente-San FranciscoSan Francisco, United StatesNo longer taking part
  • University of WashingtonSeattle, United StatesNo longer taking part
  • Prairie Education And Research CooperativeSpringfield, United StatesNo longer taking part
  • Barnes Jewish Hospital / Washington UniversitySt Louis, United StatesNo longer taking part
  • UPR-Oklahoma Heart InstituteTulsa, United StatesNo longer taking part
  • Cardiovascular Research Institute of KansasWichita, United StatesNo longer taking part
  • Lankenau Medical CenterWynnewood, United StatesNo longer taking part
  • York HospitalYork, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Surgical aortic valve replacement (SAVR)Existing treatment, for comparison

    Treatment: SAVR

  • Transcatheter aortic valve replacement (TAVR)Treatment being tested

    Treatment: SAPIEN 3 THV

Results explained

A paper that names this trial, explained in plain words.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Publications
Record updated
14 January 2026