PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
- Conditions
- Symptomatic Severe Aortic Stenosis
- Interventions
- Device: SAVR ImplantationDevice: TAVR Implantation with SAPIEN XT
- Registration Number
- NCT01314313
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
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.
- Detailed Description
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.
To assure that patients with an STS score ≥ 4% have been selected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2032
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control: SAVR SAVR Implantation SAVR (surgical aortic valve replacement) is the control arm PIIA - SAPIEN XT TAVR Implantation with SAPIEN XT PIIA is operable group
- Primary Outcome Measures
Name Time Method All-cause Death or Disabling Stroke to Two Years 2 Years All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
- Secondary Outcome Measures
Name Time Method Adjusted Days Alive and Out of Hospital (DAOH) to Two Years 2 years The number of days the patients are alive and out of the hospital.
6MWT Change From Baseline Baseline and 2 years Six Minute Walk Test change from baseline to 2 years
Effective Orifice Area (EOA) 2 years Total Aortic Regurgitation (AR) at 2 Years 2 years Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
NYHA Classification at 2 Years 2 years New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Trial Locations
- Locations (57)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Northshore
🇺🇸Evanston, Illinois, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Arkansas Heart Hospital/Clinic
🇺🇸Little Rock, Arkansas, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Washington University - Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Cooper University
🇺🇸Camden, New Jersey, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
The Heart Hospital Baylor Plano
🇺🇸Dallas, Texas, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
East Carolina Heart Institute at East Carolina University
🇺🇸Greenville, North Carolina, United States
IHC Health Services Inc. dba Intermountain Medical Center
🇺🇸Murray, Utah, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Miami Hospital Miller School of Medicine
🇺🇸Miami, Florida, United States
Indiana University Health-Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
New York Presbyterian Hospital - Cornell
🇺🇸New York, New York, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
The Lindner Center for Research & Education at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio (UTHSCSA)
🇺🇸San Antonio, Texas, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦Quebec, Canada
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma Cardiovascular Research Group
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic-Saint Marys Hospital
🇺🇸Rochester, Minnesota, United States
Providence Heart & Vascular Institute at Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
St. Paul's Hospital, Providence Health Care
🇨🇦Vancouver, British Columbia, Canada
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
The Jewish Hospital Medical Center
🇺🇸Louisville, Kentucky, United States
St. Luke's Hospital - Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Austin Heart, PLLC
🇺🇸Austin, Texas, United States