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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

A legfontosabb adatok

Hol
Atlanta, Aurora, Birmingham, Boston, Charlottesville, Cincinnati, Columbus, Dallas, Durham, Lexington, Little Rock, Los Angeles, Memphis, Murray, Nashville, New York, Philadelphia, Pittsburgh, Rochester, San Antonio, San Francisco, Seattle és St Louis (Egyesült Államok)Mind a 27 helyszín megnézése

Helyszínek itt: Egyesült Államok

  • Emory University, Children's Healthcare of AtlantaAtlanta, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Childrens Hospital of ColoradoAurora, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of Alabama at BirminghamBirmingham, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Boston Children's HospitalBoston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of Virginia (UVA)Charlottesville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Cincinnati Children's HospitalCincinnati, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The Lindner Research Center at Christ HospitalCincinnati, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Nationwide Children's HospitalColumbus, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Children's Health System of Texas / UT Southwestern Medical CenterDallas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Medical City DallasDallas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Duke University Medical CenterDurham, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of KentuckyLexington, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Arkansas Children's HospitalLittle Rock, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of California, Los AngelesLos Angeles, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • LeBonheur Children's HopsitalMemphis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Intermountain Heart Institute (IMC)Murray, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Vanderbilt UniversityNashville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Columbia University Medical Center/NYPHNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • UPMC Children's Hospital of PittsburghPittsburgh, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Mayo Clinic - RochesterRochester, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Methodist San AntonioSan Antonio, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of California, San Francisco (UCSF)San Francisco, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of Washington - Seattle Children's HospitalSeattle, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • St. Louis Children's HospitalSt Louis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Washington University Barnes- Jewish Medical/ St. Louis Children's HospitalSt Louis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part

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
NCT02744677
A regiszteradat frissítve
2026. július 23.
Eredeti leírás
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.A teljes eredeti leírásKevesebb

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Bevonási feltételek: Weight ≥ 20 kg (44 lbs.); Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use; Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg; The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Kizáró feltételek: History of or active endocarditis (active treatment with antibiotics) within the past 180 days; Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty; Interventional/surgical procedures within 30 days prior to the TPVI procedure; Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure; Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications; Participating in another investigational drug or device study that has not reached its primary endpoint; Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics); Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder; History of or current intravenous drug use; Major or progressive non-cardiac disease resulting in a life expectancy of less than one year; Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated; Inappropriate anatomy for femoral introduction and delivery of the study valve; Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI); Female who is lactating or pregnant.

ClinicalTrials.gov NCT02744677