PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
Key facts
- Where
- Atlanta, Austin, Baltimore, Boston, Camden, Charleston, Charlottesville, Chicago, Cincinnati, Clearwater, Cleveland, Dallas, Denver, Detroit, Evanston, Greenville, Houston, Indianapolis, Iowa City, Kansas City, La Jolla, Lebanon, Lincoln, Little Rock, Los Angeles, Louisville, Madison, Memphis, Miami, Mineola, Minneapolis, Murray, New Orleans, New York, Newark, Norfolk, Oklahoma City, Philadelphia, Portland, Rochester, Royal Oak, Sacramento, San Antonio, Seattle, Springfield, St Louis, Stanford, Washington D.C., and York, United StatesSee the 55 sites
Where in United States
- Emory UniversityAtlanta, United StatesNo longer taking part
- Austin Heart, PLLCAustin, United StatesNo longer taking part
- University of Maryland, BaltimoreBaltimore, United StatesNo longer taking part
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Cooper UniversityCamden, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- The Lindner Center for Research & Education at The Christ HospitalCincinnati, United StatesNo longer taking part
- Morton Plant HospitalClearwater, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- Medical City DallasDallas, United StatesNo longer taking part
- The Heart Hospital Baylor PlanoDallas, United StatesNo longer taking part
- University of Colorado HospitalDenver, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- NorthshoreEvanston, United StatesNo longer taking part
- East Carolina Heart Institute at East Carolina UniversityGreenville, United StatesNo longer taking part
- The University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
- Indiana University Health Methodist HospitalIndianapolis, United StatesNo longer taking part
- The University of IowaIowa City, United StatesNo longer taking part
- St. Luke's Hospital - Mid America Heart InstituteKansas City, United StatesNo longer taking part
- Scripps Green HospitalLa Jolla, United StatesNo longer taking part
- Scripps Memorial HospitalLa Jolla, United StatesNo longer taking part
- Dartmouth Hitchcock Medical CenterLebanon, United StatesNo longer taking part
- Nebraska Heart InstituteLincoln, United StatesNo longer taking part
- Arkansas Heart Hospital/ClinicLittle Rock, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
- The Jewish Hospital Medical CenterLouisville, United StatesNo longer taking part
- University of Wisconsin - MadisonMadison, United StatesNo longer taking part
- Baptist Memorial HospitalMemphis, United StatesNo longer taking part
- University of Miami Hospital Miller School of MedicineMiami, United StatesNo longer taking part
- Winthrop University HospitalMineola, United StatesNo longer taking part
- Minneapolis Heart Institute FoundationMinneapolis, United StatesNo longer taking part
- IHC Health Services, Inc. dba Intermountain Medical CenterMurray, United StatesNo longer taking part
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- Columbia University Medical CenterNew York, United StatesNo longer taking part
- New York Presbyterian Hospital - CornellNew York, United StatesNo longer taking part
- Newark Beth Israel Medical CenterNewark, United StatesNo longer taking part
- Sentara Norfolk General HospitalNorfolk, United StatesNo longer taking part
- Oklahoma Cardiovascular Research GroupOklahoma City, United StatesNo longer taking part
- University of Pennsylvania HospitalPhiladelphia, United StatesNo longer taking part
- Providence Heart & Vascular Institute at Providence St. Vincent Medical CenterPortland, United StatesNo longer taking part
- Mayo Clinic-Saint Marys HospitalRochester, United StatesNo longer taking part
- William Beaumont HospitalRoyal Oak, United StatesNo longer taking part
- Mercy General HospitalSacramento, United StatesNo longer taking part
- UC Davis Medical CenterSacramento, United StatesNo longer taking part
- University of Texas Health Science Center at San Antonio (UTHSCSA)San Antonio, United StatesNo longer taking part
- University of WashingtonSeattle, United StatesNo longer taking part
- Prairie Education And Research CooperativeSpringfield, United StatesNo longer taking part
- Washington University (Barnes-Jewish Hospital)St Louis, United StatesNo longer taking part
- Stanford University Medical CenterStanford, United StatesNo longer taking part
- Washington Hospital CenterWashington D.C., United StatesNo longer taking part
- York HospitalYork, United StatesNo longer taking part
Trial details
- Who runs it
- Edwards Lifesciences
- Trial code
- NCT01314313
- Record updated
- 7 March 2024
- Original description
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.Read full original descriptionShow less
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Inclusion: Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure; Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater; The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient; The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site; The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up; Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.
Exclusion: Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded; Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)]; Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+); Heart team assessment of inoperability (including examining cardiac surgeon); Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified; Preexisting mechanical or bioprosthetic valve in any position (except NR3).