THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
- Conditions
- Critical Aortic Stenosis
- Interventions
- Device: Edwards SAPIEN Transcatheter Heart ValveOther: medical management and/or balloon aortic valvuloplastyDevice: Surgical Valve Replacement
- Registration Number
- NCT00530894
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Detailed Description
Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1057
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Edwards SAPIEN Transcatheter Heart Valve Cohort A: Sapien Valve 3 Edwards SAPIEN Transcatheter Heart Valve Cohort B: Sapien Valve 4 medical management and/or balloon aortic valvuloplasty Cohort B: Medical therapy 2 Surgical Valve Replacement Cohort A: other surgical valve
- Primary Outcome Measures
Name Time Method Death 1 Year Death from any cause.
Composite of Death and Recurrence Hospitalization. duration of study Death from any cause or repeat hospitalization after intervention.
- Secondary Outcome Measures
Name Time Method Functional Change of NYHA Baseline to 1 year NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE) 1 year Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Total Hospital Days From the Index Procedure 1 year Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Change in Quality of Life (QOL) From Baseline to 1 Year Baseline and 1 Year The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.
KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.
SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
Trial Locations
- Locations (26)
Scripps Memorial Hospital/Scripps Green Hospital
🇺🇸La Jolla, California, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Heart Center Leipzig
🇩🇪Leipzig, Germany
Laval Hospital
🇨🇦Quebec, Canada
Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
New York Presbyterian Hospital - Cornell
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Vancouver St. Paul's
🇨🇦Vancouver, British Columbia, Canada
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Barnes-Jewish/Washington University
🇺🇸Saint Louis, Missouri, United States
Mayo Clinic-Saint Marys Hospital
🇺🇸Rochester, Minnesota, United States
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Boston Mass General
🇺🇸Boston, Massachusetts, United States
Brigham and Women's
🇺🇸Boston, Massachusetts, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada