Aortic Valve Replacement With Trifecta(TM)

Completed · Not applicable

Conditions studied: Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis

In brief

To confirm the clinical safety and effectiveness of the Trifecta valve.

Key facts

Study ID

NCT00475709

Run by

Abbott Medical Devices

People needed

1022

Starts

2007-06-01

Expected to finish

2012-01-01

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
• Legal age.
• Signed informed consent prior to surgery.
• Willing to complete all follow-up requirements.

You may not qualify if…

• Pregnant or nursing women.
• Have already had a valve replaced other than the aortic valve.
• Needs another valve replaced.
• Cannot return for required follow-up visits.
• Have active endocarditis.
• Acute preoperative neurological event (such as a stroke).
• Renal dialysis.
• History of substance abuse within one year, or a prison inmate.
• Participating in another study.
• Life expectancy less than two years.

Where it is running

• USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital — Los Angeles, California, United States
• Sarasota Memorial Hospital/Clinical Research Center — Sarasota, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• NYU Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Mission Hospitals — Asheville, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Main Line Health Heart Center — Wynnewood, Pennsylvania, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• Cardiothoracic and Vascular Surgeons — Austin, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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