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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Key facts

Where
Atlanta, Baltimore, Boston, Buffalo, Carmel, Charlotte, Chicago, Cincinnati, Clackamas, Cleveland, Dallas, Detroit, Elk Grove Village, Evanston, Germantown, Harrisburg, Hartford, Houston, Kansas City, La Jolla, Lebanon, Los Angeles, Loveland, Missoula, Morristown, Nashville, New Brunswick, New Lenox, New York, Newport Beach, Norfolk, North Naples, Oklahoma City, Pittsburgh, Plano, Portland, Ridgewood, Rochester, Sacramento, Saint Cloud, San Francisco, Seattle, St Louis, Stanford, Tulsa, and Wichita, United StatesSee the 58 sites

Where in United States

  • Emory University AtlantaAtlanta, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Piedmont Heart InstituteAtlanta, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • MedStar Union Memorial HospitalBaltimore, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Brigham and Women's HospitalBoston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University at Buffalo/Kaleida HealthBuffalo, United StatesContact: Edwards THV Clinical AffairsTaking people
  • St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLCCarmel, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Novant Health and Heart Vascular InstituteCharlotte, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Carolinas Health SystemCharlotte, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Rush University Medical Center ChicagoChicago, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • The Christ HospitalCincinnati, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Kaiser PortlandClackamas, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The Cleveland Clinic FoundationCleveland, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Baylor Heart and Vascular HospitalDallas, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Medical City Dallas HospitalDallas, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Henry Ford HospitalDetroit, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Alexian Brothers Hospital NetworkElk Grove Village, United StatesContact: Edwards THV Clinical AffairsTaking people
  • NorthShore University HealthSystem Research Institute EvanstonEvanston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Northwestern University ChicagoEvanston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Methodist Le Bonheur HealthcareGermantown, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Pinnacle Health HarrisburgHarrisburg, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Hartford HospitalHartford, United StatesContact: Edwards THV Clinical AffairsTaking people
  • HCA Houston Healthcare Medical CenterHouston, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Texas, Memorial HermannHouston, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Saint Luke's HospitalKansas City, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Kansas Medical CenterKansas City, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Scripps Memorial Hospital La JollaLa Jolla, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Dartmouth-Hitchcock Medical Center, HanoverLebanon, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Kaiser Los AngelesLos Angeles, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • UC Health Northern Colorado (Medical Center of the Rockies)Loveland, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • St. Patrick HospitalMissoula, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Atlantic Health System MorristownMorristown, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Centennial Medical CenterNashville, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Saint Thomas HealthNashville, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Vanderbilt University Medical CenterNashville, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Silver Cross HospitalNew Lenox, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Columbia University Medical Center/NYPHNew York, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Cornell Medical CenterNew York, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Montefiore Medical CenterNew York, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Hoag Memorial Hospital PresbyterianNewport Beach, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Sentara Norfolk General HospitalNorfolk, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Naples Community Hospital Healthcare SystemNorth Naples, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Oklahoma Cardiovascular Research Group Oklahoma CityOklahoma City, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Allegheny General HospitalPittsburgh, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The Heart Hospital Baylor PlanoPlano, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Providence Heart & Vascular Institute PortlandPortland, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • The Valley HospitalRidgewood, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Mayo Clinic - RochesterRochester, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • UC Davis Medical Center SacramentoSacramento, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Centracare Heart and Vascular CenterSaint Cloud, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Bay Area Structural Heart at Sutter HealthSan Francisco, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Kaiser San Francisco Medical CenterSan Francisco, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Washington-SeattleSeattle, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Washington University - Barnes-Jewish Hospital Saint LouisSt Louis, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Stanford UniversityStanford, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Oklahoma Heart InstituteTulsa, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas)Wichita, 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

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Trial details

Who runs it
Edwards Lifesciences
Trial code
NCT05172960
Record updated
24 September 2026
Original description
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).Read full original descriptionShow less

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Inclusion: Severe, calcific AS; Native aortic annulus size suitable for SAPIEN X4 THV; NYHA functional class ≥ II; The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion: Myocardial infarction within 30 days prior to the study procedure; Subjects with planned concomitant ablation for atrial fibrillation; Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion; Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD); Endocarditis within 180 days prior to the study procedure; Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure; Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure; Inability to tolerate or condition precluding treatment with antithrombotic therapy; Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication; Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments; Participating in another investigational drug or device study that has not reached its primary endpoint; Cardiac imaging evidence of intracardiac mass, thrombus or vegetation; Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI); Renal insufficiency and/or renal replacement therapy; Hypercoagulable state or other condition that increases risk of thrombosis; Left ventricular ejection fraction < 20%; Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system; Aortic valve is unicuspid, bicuspid or non-calcified; Pre-existing mechanical or bioprosthetic valve in any position; Severe aortic regurgitation (> 3+); Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis; Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months; Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation; Increased risk of coronary artery obstruction after THV implantation; Hypertrophic cardiomyopathy with subvalvular obstruction; Leukopenia, anemia, thrombocytopenia; Subject refuses blood products; BMI > 50 kg/m2; Estimated life expectancy < 24 months; Female who is pregnant or lactating; Subject considered to be part of a vulnerable population.

ClinicalTrials.gov NCT05172960