ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
A legfontosabb adatok
- Hol
- 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 és Wichita (Egyesült Államok)Mind a 58 helyszín megnézése
Helyszínek itt: Egyesült Államok
- Emory University AtlantaAtlanta, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Piedmont Heart InstituteAtlanta, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- MedStar Union Memorial HospitalBaltimore, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- University at Buffalo/Kaleida HealthBuffalo, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLCCarmel, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Novant Health and Heart Vascular InstituteCharlotte, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Carolinas Health SystemCharlotte, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Rush University Medical Center ChicagoChicago, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- The Christ HospitalCincinnati, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Kaiser PortlandClackamas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- The Cleveland Clinic FoundationCleveland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Baylor Heart and Vascular HospitalDallas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Medical City Dallas HospitalDallas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Henry Ford HospitalDetroit, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Alexian Brothers Hospital NetworkElk Grove Village, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- NorthShore University HealthSystem Research Institute EvanstonEvanston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Northwestern University ChicagoEvanston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Methodist Le Bonheur HealthcareGermantown, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Pinnacle Health HarrisburgHarrisburg, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Hartford HospitalHartford, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- HCA Houston Healthcare Medical CenterHouston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- University of Texas, Memorial HermannHouston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Saint Luke's HospitalKansas City, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Scripps Memorial Hospital La JollaLa Jolla, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Dartmouth-Hitchcock Medical Center, HanoverLebanon, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Kaiser Los AngelesLos Angeles, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- UC Health Northern Colorado (Medical Center of the Rockies)Loveland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- St. Patrick HospitalMissoula, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Atlantic Health System MorristownMorristown, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Centennial Medical CenterNashville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Saint Thomas HealthNashville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Silver Cross HospitalNew Lenox, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Columbia University Medical Center/NYPHNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Cornell Medical CenterNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Montefiore Medical CenterNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Hoag Memorial Hospital PresbyterianNewport Beach, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Sentara Norfolk General HospitalNorfolk, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Naples Community Hospital Healthcare SystemNorth Naples, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Oklahoma Cardiovascular Research Group Oklahoma CityOklahoma City, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Allegheny General HospitalPittsburgh, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- The Heart Hospital Baylor PlanoPlano, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Providence Heart & Vascular Institute PortlandPortland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- The Valley HospitalRidgewood, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Mayo Clinic - RochesterRochester, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- UC Davis Medical Center SacramentoSacramento, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Centracare Heart and Vascular CenterSaint Cloud, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Bay Area Structural Heart at Sutter HealthSan Francisco, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Kaiser San Francisco Medical CenterSan Francisco, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- University of Washington-SeattleSeattle, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
- Washington University - Barnes-Jewish Hospital Saint LouisSt Louis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Stanford UniversityStanford, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Oklahoma Heart InstituteTulsa, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
- Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas)Wichita, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Edwards Lifesciences
- Azonosító
- NCT05172960
- A regiszteradat frissítve
- 2026. szeptember 24.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
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).
Bevonási feltételek: 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.
Kizáró feltételek: 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.