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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

A legfontosabb adatok

Hol
Atlanta, Baltimore, Boston, Buffalo, Charlotte, Cincinnati, Clackamas, Cleveland, Detroit, Evanston, Houston, Lisle, Loveland, Morristown, Naples, Nashville, New Brunswick, New York, Newport Beach, Pittsburgh, Plano, Ridgewood, Rochester, San Francisco, Seattle, Stanford, Tulsa és Wichita (Egyesült Államok)Mind a 34 helyszín megnézése

Helyszínek itt: Egyesült Államok

  • Emory University AtlantaAtlanta, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Piedmont Heart InstituteAtlanta, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • MedStar Union Memorial HospitalBaltimore, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • University of BuffaloBuffalo, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Novant Health and Vascular InstituteCharlotte, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Carolinas Health SystemCharlotte, 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 AffairsRésztvevőt keres
  • Henry Ford Hospital_DetroitDetroit, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Northwestern University ChicagoEvanston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of Texas, Memorial HermannHouston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Alexian Brothers Hospital NetworkLisle, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • UC Health Medical Center of the RockiesLoveland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Atlantic Health System MorristownMorristown, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Naples Community Hospital Healthcare SystemNaples, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Saint Thomas HealthNashville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Robert Wood Johnson University HospitalNew Brunswick, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Columbia University Medical Center/NYPHNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Cornelll University New YorkNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Montefiore Medical CenterNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Hoag Memorial Hospital PresbyterianNewport Beach, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Allegheny General HospitalPittsburgh, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The Heart Hospital Baylor PlanoPlano, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The Valley HospitalRidgewood, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Mayo ClinicRochester, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Rochester General HospitalRochester, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Bay Area Structural Heart at Sutter HealthSan Francisco, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Kaiser San FranciscoSan Francisco, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Washington-SeattleSeattle, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Stanford University Medical CenterStanford, 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

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

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

Oldal nyomtatása az orvosomnak

A vizsgálat adatai

Ki végzi
Edwards Lifesciences
Azonosító
NCT05172973
A regiszteradat frissítve
2026. október 7.
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 who are at high or greater risk with a failing aortic bioprosthetic valve.A teljes eredeti leírásKevesebb

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Bevonási feltételek: Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency; Bioprosthetic valve size suitable for SAPIEN X4 THV; NYHA functional class ≥ II; Heart Team agrees the subject is at high or greater surgical risk; The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Kizáró feltételek: Surgical or transcatheter valve in the mitral position; 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. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion; Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure; 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; Clinically significant coronary artery disease requiring revascularization; 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; Failing valve has moderate or severe paravalvular regurgitation; Failing valve is unstable, rocking, or not structurally intact; Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve; Increased risk of THV embolization; Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis; Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months; Increased risk of coronary artery obstruction after THV implantation; Hypertrophic cardiomyopathy with subvalvular obstruction; Leukopenia, anemia, thrombocytopenia; Subject refuses blood products; Body mass index > 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 NCT05172973