THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

Completed · Not applicable

Conditions studied: Critical Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT00530894

Run by

Edwards Lifesciences

People needed

1057

Starts

2007-04-01

Expected to finish

2017-07-01

Last updated by the study team

2017-09-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
• Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
• Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
• Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.

Where it is running

• Scripps Memorial Hospital/Scripps Green Hospital — La Jolla, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, 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
• Mayo Clinic-Saint Marys Hospital — Rochester, Minnesota, United States
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Barnes-Jewish/Washington University — St Louis, Missouri, United States
• New York Presbyterian Hospital - Cornell — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical City Dallas — Dallas, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Vancouver St. Paul's — Vancouver, British Columbia, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Laval Hospital — Québec, Canada

Full record on ClinicalTrials.gov

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