Aortic Valve Replacement With Trifecta(TM)
To confirm the clinical safety and effectiveness of the Trifecta valve.
Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis
Device: Trifecta Aortic Heart Valve
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Observational, Prospective Evaluation of the Trifecta Valve|
- Late Adverse Event Rates [ Time Frame: Events occurring greater than or equal to 31 days post-implant. ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
|Study Start Date:||June 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Trifecta Aortic Heart Valve
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Device: Trifecta Aortic Heart Valve
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
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.
|United States, California|
|USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Sarasota Memorial Hospital/Clinical Research Center|
|Sarasota, Florida, United States, 34239|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|NYU Medical Center|
|New York, New York, United States, 10016|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Asheville, North Carolina, United States, 28801|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania Health System|
|Philadelphia, Pennsylvania, United States, 19104|
|Main Line Health Heart Center|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, Tennessee|
|Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|Cardiothoracic and Vascular Surgeons|
|Austin, Texas, United States, 78756|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Intermountain Medical Center|
|Murray, Utah, United States, 84157|
|United States, Wisconsin|
|Aurora St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Hartzell Schaff, MD||Mayo Clinic|