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Taking people in United StatesNo phase

PARTNER 3 Trial - Aortic Valve-in-Valve

Key facts

Where
Atlanta, Atlantis, Austin, Boston, Buffalo, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Dallas, Detroit, Evanston, Fairfax, Gainesville, Hartford, Houston, Kansas City, Lebanon, Lincoln, Los Angeles, Loveland, Madison, Memphis, Mineola, Minneapolis, Murray, Nashville, New Orleans, New York, Newark, Norfolk, Oklahoma City, Philadelphia, Phoenix, Pittsburgh, Portland, Raleigh, Rochester, Royal Oak, Sacramento, San Francisco, Springfield, St Louis, Stanford, and Wynnewood, United StatesSee the 50 sites

Where in United States

  • Emory University HospitalAtlanta, United StatesContact: Edwards THV Clinical AffairsTaking people
  • JFK Medical Center/ Atlantic Clinical Research CollaborativeAtlantis, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Austin Heart, PLLCAustin, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Brigham and Women's HospitalBoston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of BuffaloBuffalo, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Carolina's Health SystemCharlotte, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of VirginiaCharlottesville, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Northwestern University HospitalChicago, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Rush University Medical CenterChicago, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The Christ HospitalCincinnati, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The Cleveland Clinic FoundationCleveland, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Medical City Dallas HospitalDallas, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The Heart Hospital Baylor PlanoDallas, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Henry Ford HospitalDetroit, United StatesContact: Edwards THV Clinical AffairsTaking people
  • NorthShore University HealthSystemEvanston, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Inova Heart and vascular Instritute (Fairfax Inova)Fairfax, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Florida - GainesvilleGainesville, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Hartford HospitalHartford, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The University of Texas Health Science Center at HoustonHouston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Saint Luke's Hospital of Kansas City Mid AmericaKansas City, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Nebraska Heart InstituteLincoln, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of California, Los AngelesLos Angeles, United StatesContact: Edwards THV Clinical AffairsTaking people
  • UC Health Northern Colorado (Medical Center of the Rockies)Loveland, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of Wisconsin - MadisonMadison, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Baptist Memorial HospitalMemphis, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Winthrop University HospitalMineola, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of Minnesota Medical CenterMinneapolis, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Intermountain Medical CenterMurray, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Saint Thomas Health ServicesNashville, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Ochsner Clinic FoundationNew Orleans, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Columbia University Medical Center/New York-Presbyterian HospitalNew York, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Cornell UniversityNew York, United StatesContact: Edwards THV Clinical AffairsTaking people
  • New York University (NYU) Langone Medical CenterNew York, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Newark Beth IsraelNewark, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Sentara Cardiovascular Research InstituteNorfolk, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Oklahoma Cardiovascular Research GroupOklahoma City, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Pennsylvania HospitalPhiladelphia, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Banner University Medical CenterPhoenix, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Allegheny General HospitalPittsburgh, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Providence Heart & Vascular InstitutePortland, United StatesContact: Edwards THV Clinical AffairsTaking people
  • NC Heart and Vascular (Rex Hospital)Raleigh, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Mayo ClinicRochester, United StatesContact: Edwards THV Clinical AffairsTaking people
  • William Beaumont HospitalRoyal Oak, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Sutter Medical CenterSacramento, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Kaiser Permanente-San FranciscoSan Francisco, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Prairie Education And Research CooperativeSpringfield, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Washington University (Barnes-Jewish Hospital)St Louis, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Stanford University Medical CenterStanford, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Lankenau Medical CenterWynnewood, United StatesContact: Edwards THV Clinical AffairsTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Edwards Lifesciences
Trial code
NCT03003299
Record updated
10 May 2024
Original description
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.Read full original descriptionShow less

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Inclusion: Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency; Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm; NYHA Functional Class ≥ II; Heart Team agrees the patient is low to intermediate risk; Heart Team agrees valve implantation will likely benefit the patient; The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion: Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion); Evidence of an acute myocardial infarction ≤ 30 days before enrollment; Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion; Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation; Emergency interventional/surgical procedures within 30 days prior to the procedure; Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure; Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure; Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication; Currently participating in an investigational drug or another device study; Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states; Untreated clinically significant coronary artery disease requiring revascularization; Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment; Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation; Stroke or transient ischemic attack within 90 days of enrollment; Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment; Renal insufficiency and/or renal replacement therapy at the time of screening; LVEF < 30%; Positive urine or serum pregnancy test in female subjects of childbearing potential; Severe regurgitation (> 3+) or stenosis of any other valve; Failing valve has moderate or severe paravalvular regurgitation; Failing valve is unstable, rocking, or not structurally intact; Increased risk of coronary obstruction by prosthetic leaflets of the failing valve; Increased risk of embolization of THV; Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve; Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral); Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic); Anatomical characteristics that would preclude safe access to the apex (Transapical); Hypertrophic cardiomyopathy with obstruction; Active bacterial endocarditis within 180 days of the procedure; Patient refuses blood products; Estimated life expectancy < 24 months.

ClinicalTrials.gov NCT03003299