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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

PARTNER 3 Trial - Aortic Valve-in-Valve

A legfontosabb adatok

Hol
Atlanta, Atlantis, Austin, Boston, Buffalo, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Dallas, Detroit, Evanston, Fairfax, Gainesville, Hartford, Houston, Kansas City, Lebanon, Lincoln, Los Angeles, Loveland, Madison, Memphis, Mineola, Minneapolis, Murray, Nashville, New Orleans, New York, Newark, Norfolk, Oklahoma City, Philadelphia, Phoenix, Pittsburgh, Portland, Raleigh, Rochester, Royal Oak, Sacramento, San Francisco, Springfield, St Louis, Stanford és Wynnewood (Egyesült Államok)Mind a 50 helyszín megnézése

Helyszínek itt: Egyesült Államok

  • Emory University HospitalAtlanta, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • JFK Medical Center/ Atlantic Clinical Research CollaborativeAtlantis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Austin Heart, PLLCAustin, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Brigham and Women's HospitalBoston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of BuffaloBuffalo, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Carolina's Health SystemCharlotte, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • University of VirginiaCharlottesville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Northwestern University HospitalChicago, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Rush University Medical CenterChicago, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The Christ HospitalCincinnati, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The Cleveland Clinic FoundationCleveland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Medical City Dallas HospitalDallas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The Heart Hospital Baylor PlanoDallas, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Henry Ford HospitalDetroit, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • NorthShore University HealthSystemEvanston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Inova Heart and vascular Instritute (Fairfax Inova)Fairfax, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Florida - GainesvilleGainesville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Hartford HospitalHartford, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • The University of Texas Health Science Center at HoustonHouston, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Saint Luke's Hospital of Kansas City Mid AmericaKansas City, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Dartmouth Hitchcock Medical CenterLebanon, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Nebraska Heart InstituteLincoln, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • University of California, Los AngelesLos Angeles, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • UC Health Northern Colorado (Medical Center of the Rockies)Loveland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of Wisconsin - MadisonMadison, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Baptist Memorial HospitalMemphis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Winthrop University HospitalMineola, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • University of Minnesota Medical CenterMinneapolis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Intermountain Medical CenterMurray, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Saint Thomas Health ServicesNashville, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Ochsner Clinic FoundationNew Orleans, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Columbia University Medical Center/New York-Presbyterian HospitalNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Cornell UniversityNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • New York University (NYU) Langone Medical CenterNew York, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Newark Beth IsraelNewark, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Sentara Cardiovascular Research InstituteNorfolk, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Oklahoma Cardiovascular Research GroupOklahoma City, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • University of Pennsylvania HospitalPhiladelphia, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Banner University Medical CenterPhoenix, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Allegheny General HospitalPittsburgh, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Providence Heart & Vascular InstitutePortland, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • NC Heart and Vascular (Rex Hospital)Raleigh, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Mayo ClinicRochester, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • William Beaumont HospitalRoyal Oak, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Sutter Medical CenterSacramento, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Kaiser Permanente-San FranciscoSan Francisco, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Prairie Education And Research CooperativeSpringfield, Egyesült ÁllamokContact: Edwards THV Clinical AffairsNo longer taking part
  • Washington University (Barnes-Jewish Hospital)St Louis, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Stanford University Medical CenterStanford, Egyesült ÁllamokContact: Edwards THV Clinical AffairsRésztvevőt keres
  • Lankenau Medical CenterWynnewood, 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
NCT03003299
A regiszteradat frissítve
2024. május 10.
Eredeti leírás
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.A teljes eredeti leírásKevesebb

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Bevonási feltételek: Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency; Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm; NYHA Functional Class ≥ II; Heart Team agrees the patient is low to intermediate risk; Heart Team agrees valve implantation will likely benefit the patient; The study patient 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 (mitral rings are not an exclusion); Evidence of an acute myocardial infarction ≤ 30 days before enrollment; Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion; Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation; Emergency interventional/surgical procedures within 30 days prior to the procedure; Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure; Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure; Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication; Currently participating in an investigational drug or another device study; Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states; Untreated clinically significant coronary artery disease requiring revascularization; Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment; Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation; Stroke or transient ischemic attack within 90 days of enrollment; Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment; Renal insufficiency and/or renal replacement therapy at the time of screening; LVEF < 30%; Positive urine or serum pregnancy test in female subjects of childbearing potential; Severe regurgitation (> 3+) or stenosis of any other valve; Failing valve has moderate or severe paravalvular regurgitation; Failing valve is unstable, rocking, or not structurally intact; Increased risk of coronary obstruction by prosthetic leaflets of the failing valve; Increased risk of embolization of THV; Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve; Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral); Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic); Anatomical characteristics that would preclude safe access to the apex (Transapical); Hypertrophic cardiomyopathy with obstruction; Active bacterial endocarditis within 180 days of the procedure; Patient refuses blood products; Estimated life expectancy < 24 months.

ClinicalTrials.gov NCT03003299