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

Abbott Medical Devices245 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Heart Valve Diseases

Interventions

Trifecta valveDEVICE

surgical replacement of aortic valve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Subject currently participating in another device or drug study * Subject unable or unwilling to return for study follow-up visits

Locations (6)

Abbott Northwestern Hospital Cardiac Surgical Associates

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Mission Hospital

Asheville, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Late Adverse Event Incidence

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:\[(Number of late adverse events/sum of late patient years) x 100\]

Time frame: 5 years

Secondary Outcomes

Characterize Patient NYHA Functional Classification Status

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.

Time frame: 5 years

Report the Hemodynamic Performance of the Valve

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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