Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Not Applicable

Completed

Brief Summary: To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

Detailed Description: To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

Recruitment & Eligibility

Inclusion Criteria

Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
Subject met eligibility criteria of IDE study
Subject agrees to complete study follow-up visits
Subject provides written informed consent

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Trifecta Valve Group	Trifecta valve	Subjects implanted with a Trifecta valve.

Primary Outcome Measures

Name	Time	Method
Late Adverse Event Incidence	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:\[(Number of late adverse events/sum of late patient years) x 100\]

Secondary Outcome Measures

Name	Time	Method
Characterize Patient NYHA Functional Classification Status	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	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.

Locations (6): Intermountain Heart & Lung Surgical Associates
🇺🇸
Murray, Utah, United States
Abbott Northwestern Hospital Cardiac Surgical Associates
🇺🇸
Minneapolis, Minnesota, United States
Vanderbilt Heart Institute
🇺🇸
Nashville, Tennessee, United States
Mission Hospital
🇺🇸
Asheville, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States