The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
- Conditions
- SevereSymptomaticCalcific Aortic Stenosis
- Interventions
- Device: TAVR Implantation with SAPIEN XTDevice: TAVR Implantation with SAPIEN
- Registration Number
- NCT02184442
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Detailed Description
Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).
Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 560
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR - SAPIEN XT TAVR Implantation with SAPIEN XT TAVR (transaortic valve replacement) with SAPIEN XT TAVR - SAPIEN TAVR Implantation with SAPIEN TAVR (transaortic valve replacement) with SAPIEN is the control arm
- Primary Outcome Measures
Name Time Method Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization 1 Year All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
- Secondary Outcome Measures
Name Time Method NYHA Classification - Change From Baseline Baseline and 1 Year 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.
Total Aortic Regurgitation - Change From Baseline 1 Year 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 one year was analyzed in the valve implant population.Effective Orifice Area - Change From Baseline 1 Year
Trial Locations
- Locations (53)
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Newark Beth Israel
🇺🇸Newark, New Jersey, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
University of Miami
🇺🇸Miami, Florida, United States
Indiana University Health-Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Northwestern Hospital
🇺🇸Chicago, Illinois, United States
University of Louisville - Jewish Hospital
🇺🇸Louisville, Kentucky, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Washington University - Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Saint Luke's Hospital of Kansas City Mid America
🇺🇸Kansas City, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
North Shore University Hospital, NY
🇺🇸Manhasset, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
East Carolina Heart Institute at East Carolina University
🇺🇸Greenville, North Carolina, United States
Medical University of South Carolina Charleston
🇺🇸Charleston, North Carolina, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The Heart Hospital Baylor Plano
🇺🇸Dallas, Texas, United States
Austin Heart, PLLC
🇺🇸Austin, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
The Christ Hospital, Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio (UTHSCSA)
🇺🇸San Antonio, Texas, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
York Hospital
🇺🇸York, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Arkansas Heart Hospital/Clinic
🇺🇸Little Rock, Arkansas, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
University of Florida, Gainesville
🇺🇸Gainesville, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Washington Hospital Center (WHC)
🇺🇸Washington, District of Columbia, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Cornell University
🇺🇸New York, New York, United States