PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
A legfontosabb adatok
- Hol
- Albany, Atlanta, Atlantis, Auburn, Austin, Birmingham, Boston, Buffalo, Burlingame, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Detroit, Evanston, Falls Church, Gainesville, Hartford, Honolulu, Houston, Iowa City, Kansas City, Lebanon, Lincoln, Los Angeles, Loveland, Madison, Memphis, Miami Beach, Mineola, Minneapolis, Morristown, Nashville, New Orleans, New York, Newark, Newport Beach, Norfolk, Oklahoma City, Orlando, Palo Alto, Philadelphia, Phoenix, Pittsburgh, Plano, Portland, Raleigh, Rochester, Royal Oak, Sacramento, Salt Lake City, San Francisco, Seattle, Springfield, St Louis, Tulsa, Wichita, Wynnewood és York (Egyesült Államok)Mind a 68 helyszín megnézése
Helyszínek itt: Egyesült Államok
- AlbanyAlbany, Egyesült ÁllamokNo longer taking part
- Emory UniversityAtlanta, Egyesült ÁllamokNo longer taking part
- JFK Medical Center/ Atlantic Clinical Research CollaborativeAtlantis, Egyesült ÁllamokNo longer taking part
- Central Maine Medical CenterAuburn, Egyesült ÁllamokNo longer taking part
- Austin HeartAustin, Egyesült ÁllamokNo longer taking part
- University of AlabamaBirmingham, Egyesült ÁllamokNo longer taking part
- Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
- University of BuffaloBuffalo, Egyesült ÁllamokNo longer taking part
- Mills Peninsula Health ServicesBurlingame, Egyesült ÁllamokNo longer taking part
- Carolina's Health SystemCharlotte, Egyesült ÁllamokNo longer taking part
- UPR - Novant Health Heart and Vascular InstitutionCharlotte, Egyesült ÁllamokNo longer taking part
- University of VirginiaCharlottesville, Egyesült ÁllamokNo longer taking part
- Northwestern UniversityChicago, Egyesült ÁllamokNo longer taking part
- Rush University Medical CenterChicago, Egyesült ÁllamokNo longer taking part
- The Christ Hospital- CincinnatiCincinnati, Egyesült ÁllamokNo longer taking part
- Cleveland Clinic FoundationCleveland, Egyesült ÁllamokNo longer taking part
- Mount Carmel Health SystemColumbus, Egyesült ÁllamokNo longer taking part
- Medical City Dallas HospitalDallas, Egyesült ÁllamokNo longer taking part
- Henry Ford HospitalDetroit, Egyesült ÁllamokNo longer taking part
- NorthShore University HealthSystem Research InstituteEvanston, Egyesült ÁllamokNo longer taking part
- Fairfax INOVAFalls Church, Egyesült ÁllamokNo longer taking part
- University of Florida - GainesvilleGainesville, Egyesült ÁllamokNo longer taking part
- HartfordHartford, Egyesült ÁllamokNo longer taking part
- The Queen's Medical CenterHonolulu, Egyesült ÁllamokNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, 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
- Dartmouth Hitchcock Medical CenterLebanon, Egyesült ÁllamokNo longer taking part
- Nebraska Heart InstituteLincoln, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- University of California Los Angeles - Ronald Reagan Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- UC Health Northern Colorado (Medical Center of the Rockies)Loveland, Egyesült ÁllamokNo longer taking part
- University of WisconsinMadison, Egyesült ÁllamokNo longer taking part
- Baptist Memorial HospitalMemphis, Egyesült ÁllamokNo longer taking part
- Mount Sinai Medical CenterMiami Beach, Egyesült ÁllamokNo longer taking part
- Winthrop University HospitalMineola, Egyesült ÁllamokNo longer taking part
- University of Minnesota Medical CenterMinneapolis, Egyesült ÁllamokNo longer taking part
- Morristown Medical Center / Atlantic Health System HospitalMorristown, Egyesült ÁllamokNo longer taking part
- Saint Thomas Health ServicesNashville, Egyesült ÁllamokNo longer taking part
- Ochsner Clinic FoundationNew Orleans, Egyesült ÁllamokNo longer taking part
- UPR - Louisiana State University Health Science CenterNew 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
- NYU Medical CenterNew York, Egyesült ÁllamokNo longer taking part
- Newark Beth IsraelNewark, Egyesült ÁllamokNo longer taking part
- Hoag HospitalNewport Beach, Egyesült ÁllamokNo longer taking part
- Sentara Cardiovascular Research InstituteNorfolk, Egyesült ÁllamokNo longer taking part
- Oklahoma Cardiovascular Research GroupOklahoma City, Egyesült ÁllamokNo longer taking part
- Florida HospitalOrlando, Egyesült ÁllamokNo longer taking part
- Stanford Hospital and ClinicsPalo Alto, Egyesült ÁllamokNo longer taking part
- University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- Banner University Medical CenterPhoenix, Egyesült ÁllamokNo longer taking part
- Allegheny General HospitalPittsburgh, Egyesült ÁllamokNo longer taking part
- The Heart Hosptial Baylor PlanoPlano, Egyesült ÁllamokNo longer taking part
- Providence Heart & Vascular InstitutePortland, Egyesült ÁllamokNo longer taking part
- Rex Hospital / NC Heart and Vascular ResearchRaleigh, Egyesült ÁllamokNo longer taking part
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- William Beaumont HospitalRoyal Oak, Egyesült ÁllamokNo longer taking part
- Sutter Health SacramentoSacramento, Egyesült ÁllamokNo longer taking part
- Intermountain Medical CenterSalt Lake City, Egyesült ÁllamokNo longer taking part
- Kaiser Permanente-San FranciscoSan Francisco, Egyesült ÁllamokNo longer taking part
- University of WashingtonSeattle, Egyesült ÁllamokNo longer taking part
- Prairie Education And Research CooperativeSpringfield, Egyesült ÁllamokNo longer taking part
- Barnes Jewish Hospital / Washington UniversitySt Louis, Egyesült ÁllamokNo longer taking part
- UPR-Oklahoma Heart InstituteTulsa, 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
- NCT02675114
- A regiszteradat frissítve
- 2026. január 14.
- Eredeti leírás
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.A teljes eredeti leírásKevesebb
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
Bevonási feltételek: Severe, calcific aortic stenosis; New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%; Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4; The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Kizáró feltételek: Evidence of an acute myocardial infarction ≤ 30 days before randomization; Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure; Severe lung disease or currently on home oxygen; Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation; 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; Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve; Complex coronary artery disease:; Unprotected left main coronary artery; Syntax score > 32; Heart Team assessment that optimal revascularization cannot be performed; 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 at the time of screening; 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 or cannulation and aortotomy for surgical aortic valve replacement; Ventricular dysfunction with LVEF < 30%; Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath; Aortic valve is unicuspid, bicuspid, or non-calcified; Severe aortic regurgitation (>3+); Severe mitral regurgitation (>3+) ≥ moderate 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; Body mass index > 50 kg/m2; Estimated life expectancy < 24 months; Immobility that would prevent completion of study procedures; Patient is not a candidate for both arms of the study.