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

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

Detailed Description
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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.

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

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: Trifecta valve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trifecta Valve Group<br>Subjects implanted with a Trifecta valve. | Device: Trifecta valve<br>* surgical replacement of aortic valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trifecta Valve