Aortic Valve Replacement With Trifecta(TM)

Not Applicable

Completed

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

Interventions: Device: Trifecta Aortic Heart Valve

Registration Number: NCT00475709

Lead Sponsor: Abbott Medical Devices

Brief Summary: To confirm the clinical safety and effectiveness of the Trifecta valve.

Detailed Description: The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1022

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trifecta Aortic Heart Valve	Trifecta Aortic Heart Valve	All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.

Primary Outcome Measures

Name	Time	Method
Late Adverse Event Rates	Events occurring greater than or equal to 31 days post-implant.	Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
Characterize Patient NYHA Functional Classification Status.	1 year	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.
Characterize the Hemodynamic Performance of the Valve.	1 year	Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (18): Sarasota Memorial Hospital/Clinical Research Center
🇺🇸
Sarasota, Florida, United States
Loyola University Medical Center
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Maywood, Illinois, United States
Cleveland Clinic Foundation
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Cleveland, Ohio, United States
University of Pennsylvania Health System
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Philadelphia, Pennsylvania, United States
Baylor College of Medicine
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Houston, Texas, United States
NYU Medical Center
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New York, New York, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Vanderbilt Medical Center
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Nashville, Tennessee, United States
Duke University Medical Center
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Durham, North Carolina, United States
Abbott Northwestern Hospital
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Minneapolis, Minnesota, United States
Columbia University Medical Center
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New York, New York, United States
Mission Hospitals
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Asheville, North Carolina, United States
Cardiothoracic and Vascular Surgeons
🇺🇸
Austin, Texas, United States
USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital
🇺🇸
Los Angeles, California, United States
Main Line Health Heart Center
🇺🇸
Wynnewood, Pennsylvania, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Aurora St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States