Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
1022 participants
INTERVENTIONAL
2007-06-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trifecta Aortic Heart Valve
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Trifecta Aortic Heart Valve
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
Interventions
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Trifecta Aortic Heart Valve
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
Eligibility Criteria
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Inclusion Criteria
* Legal age.
* Signed informed consent prior to surgery.
* Willing to complete all follow-up requirements.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Hartzell Schaff, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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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
Countries
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Other Identifiers
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CS0501
Identifier Type: -
Identifier Source: org_study_id
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