Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve|
- Late Adverse Event Incidence [ Time Frame: 5 years ]
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: 5 years ]
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.
- Report the Hemodynamic Performance of the Valve [ Time Frame: 5 years ]
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:||February 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Trifecta Valve Group
Subjects implanted with a Trifecta valve.
Device: Trifecta valve
surgical replacement of aortic valve
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514162
|United States, Minnesota|
|Abbott Northwestern Hospital Cardiac Surgical Associates|
|Minneapolis, Minnesota, United States, 55407|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|Asheville, North Carolina, United States, 28801|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Vanderbilt Heart Institute|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|Intermountain Heart & Lung Surgical Associates|
|Murray, Utah, United States, 84157|