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EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

A legfontosabb adatok

Hol
Albany, Atlanta, Baltimore, Boston, Buffalo, Burlingame, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Clackamas, Cleveland, Columbus, Dallas, Detroit, Evanston, Everett, Falls Church, Gainesville, Harrisburg, Houston, Hyannis, Iowa City, Kansas City, Lebanon, Lisle, Los Angeles, Loveland, Milwaukee, Mineola, Minneapolis, Missoula, Morristown, Murray, Nashville, New Haven, New Orleans, New York, Newark, Newport Beach, Norfolk, Pasadena, Phoenix, Piscataway, Pittsburgh, Portland, Raleigh, Roanoke, Rochester, Sacramento, Saint Cloud, San Francisco, Seattle, Spokane, Springfield, Stanford, Stony Brook, The Bronx, Washington D.C., West Des Moines, Wichita, Wynnewood és York (Egyesült Államok)Mind a 74 helyszín megnézése

Helyszínek itt: Egyesült Államok

  • Albany Medical CollegeAlbany, Egyesült ÁllamokNo longer taking part
  • Emory UniversityAtlanta, Egyesült ÁllamokNo longer taking part
  • Piedmont Heart InstituteAtlanta, Egyesült ÁllamokNo longer taking part
  • University of Maryland Medical CenterBaltimore, Egyesült ÁllamokNo longer taking part
  • Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
  • University at Buffalo/Kaleida HealthBuffalo, Egyesült ÁllamokNo longer taking part
  • Mills Peninsula Health ServicesBurlingame, Egyesült ÁllamokNo longer taking part
  • CAMC Clinical Trials CenterCharleston, Egyesült ÁllamokNo longer taking part
  • Carolina's Health SystemCharlotte, Egyesült ÁllamokNo longer taking part
  • University of VirginiaCharlottesville, Egyesült ÁllamokNo longer taking part
  • Northwestern UniversityChicago, Egyesült ÁllamokNo longer taking part
  • Rush University Medical Center ChicagoChicago, Egyesült ÁllamokNo longer taking part
  • The Christ Hospital- CincinnatiCincinnati, Egyesült ÁllamokNo longer taking part
  • Kaiser PortlandClackamas, Egyesült ÁllamokNo longer taking part
  • Cleveland Clinic FoundationCleveland, Egyesült ÁllamokNo longer taking part
  • Mount Carmel Health SystemColumbus, Egyesült ÁllamokNo longer taking part
  • The Ohio Health Research InstituteColumbus, Egyesült ÁllamokNo longer taking part
  • Texas Health Physician GroupDallas, Egyesült ÁllamokNo longer taking part
  • The Heart Hospital Baylor PlanoDallas, Egyesült ÁllamokNo longer taking part
  • Henry Ford HospitalDetroit, Egyesült ÁllamokNo longer taking part
  • NorthShore University HealthSystem Research InstitutionEvanston, Egyesült ÁllamokNo longer taking part
  • Providence EverettEverett, Egyesült ÁllamokNo longer taking part
  • Inova Heart and Vascular Institute (Fairfax Inova)Falls Church, Egyesült ÁllamokNo longer taking part
  • The Cardiac & Vascular Institute Research FoundationGainesville, Egyesült ÁllamokNo longer taking part
  • University of FloridaGainesville, Egyesült ÁllamokNo longer taking part
  • Pinnacle HealthHarrisburg, Egyesült ÁllamokNo longer taking part
  • University of Texas Health Science Center at HoustonHouston, Egyesült ÁllamokNo longer taking part
  • Cape Cod HospitalHyannis, Egyesült ÁllamokNo longer taking part
  • University of Iowa Hospitals and ClinicsIowa City, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Hospital of Kansas City Mid AmericaKansas City, Egyesült ÁllamokNo longer taking part
  • Mary Hitchcock Memorial HospitalLebanon, Egyesült ÁllamokNo longer taking part
  • Alexian Brothers Hospital NetworkLisle, Egyesült ÁllamokNo longer taking part
  • Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
  • UC Health Northern Colorado (Medical Center of the Rockies)Loveland, Egyesült ÁllamokNo longer taking part
  • Medical College of WisconsinMilwaukee, Egyesült ÁllamokNo longer taking part
  • NYU Langone Hosptial - Long IslandMineola, Egyesült ÁllamokNo longer taking part
  • Minneapolis Heart InstituteMinneapolis, Egyesült ÁllamokNo longer taking part
  • University of Minnesota Medical CenterMinneapolis, Egyesült ÁllamokNo longer taking part
  • St. Patrick HospitalMissoula, Egyesült ÁllamokNo longer taking part
  • Atlantic Health System Hospital Corp - Morristown Medical CenterMorristown, Egyesült ÁllamokNo longer taking part
  • Intermountain Medical Center Salt Lake CityMurray, Egyesült ÁllamokNo longer taking part
  • Vanderbilt University Medical CenterNashville, Egyesült ÁllamokNo longer taking part
  • Yale UniversityNew Haven, Egyesült ÁllamokNo longer taking part
  • Ochsner Clinic FoundationNew Orleans, Egyesült ÁllamokNo longer taking part
  • Columbia University Medical Center/New York-Presbyterian HospitalNew York, Egyesült ÁllamokNo longer taking part
  • Cornell UniversityNew York, Egyesült ÁllamokNo longer taking part
  • New York University Langone Medical CenterNew York, Egyesült ÁllamokNo longer taking part
  • Newark Beth Israel Medical CenterNewark, Egyesült ÁllamokNo longer taking part
  • Hoag Memorial Hospital PresbyterianNewport Beach, Egyesült ÁllamokNo longer taking part
  • Sentara Cardiovascular Research InstituteNorfolk, Egyesült ÁllamokNo longer taking part
  • Huntington HospitalPasadena, Egyesült ÁllamokNo longer taking part
  • Banner University Medical CenterPhoenix, Egyesült ÁllamokNo longer taking part
  • Rutgers - Robert Wood Johnson Medical SchoolPiscataway, Egyesült ÁllamokNo longer taking part
  • Allegheny-Singer Research InstitutePittsburgh, Egyesült ÁllamokNo longer taking part
  • Maine Medical CenterPortland, Egyesült ÁllamokNo longer taking part
  • NC Heart and Vascular (Rex Hospital)Raleigh, Egyesült ÁllamokNo longer taking part
  • Carilion Medical CenterRoanoke, Egyesült ÁllamokNo longer taking part
  • Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
  • Rochester General HospitalRochester, Egyesült ÁllamokNo longer taking part
  • UC Davis Medical CenterSacramento, Egyesült ÁllamokNo longer taking part
  • CentraCare HeartSaint Cloud, Egyesült ÁllamokNo longer taking part
  • Kaiser San Francisco Medical CenterSan Francisco, Egyesült ÁllamokNo longer taking part
  • Swedish Medical CenterSeattle, Egyesült ÁllamokNo longer taking part
  • University of WashingtonSeattle, Egyesült ÁllamokNo longer taking part
  • Sacred Heart Medical CenterSpokane, Egyesült ÁllamokNo longer taking part
  • Prairie Education And Research CooperativeSpringfield, Egyesült ÁllamokNo longer taking part
  • Stanford Hospital and Clinics Palo AltoStanford, Egyesült ÁllamokNo longer taking part
  • Stony Brook University Medical CenterStony Brook, Egyesült ÁllamokNo longer taking part
  • Montefiore Medical CenterThe Bronx, Egyesült ÁllamokNo longer taking part
  • Washington Hospital Center DCWashington D.C., Egyesült ÁllamokNo longer taking part
  • Iowa Heart CenterWest Des Moines, Egyesült ÁllamokNo longer taking part
  • Cardiovascular Research Institute of KansasWichita, Egyesült ÁllamokNo longer taking part
  • Lankenau Medical CenterWynnewood, Egyesült ÁllamokNo longer taking part
  • York HospitalYork, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
Edwards Lifesciences
Azonosító
NCT03042104
A regiszteradat frissítve
2024. május 13.
Eredeti leírás
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.A teljes eredeti leírásKevesebb

Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Bevonási feltételek: 65 years of age or older; Severe aortic stenosis; Patient is asymptomatic; LV ejection fraction ≥ 50%; Society of Thoracic Surgeons (STS) risk score ≤ 10; The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Kizáró feltételek: Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication; Evidence of an acute myocardial infarction ≤ 30 days before randomization; Inability to tolerate or condition precluding treatment with anti-thrombotic therapy; Severe lung disease or currently on home oxygen; Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication; Currently participating in an investigational drug or another device study; Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments; Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization; Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states; Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization; Cardiac imaging evidence of intracardiac mass, thrombus or vegetation; Stroke or transient ischemic attack within 90 days of randomization; Renal insufficiency and/or renal replacement therapy; Severe pulmonary hypertension; History of cirrhosis or any active liver disease; Significant frailty as determined by the Heart Team; Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system; Patient is symptomatic; Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV; Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath; Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR; Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified; Severe aortic regurgitation (>3+); Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis; Pre-existing mechanical or bioprosthetic valve in any position; Hypertrophic cardiomyopathy with obstruction; Active bacterial endocarditis within 180 days of randomization; Patient refuses blood products; BMI >50 kg/m2; Estimated life expectancy <24 months.

ClinicalTrials.gov NCT03042104