Aortic Valve Replacement With Trifecta(TM)

Study Overview
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Brief Summary
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To confirm the clinical safety and effectiveness of the Trifecta valve.

Detailed Description
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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.

Official Title
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An Observational, Prospective Evaluation of the Trifecta Valve

Conditions
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Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis

Intervention / Treatment
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* Device: Trifecta Aortic Heart Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time). Legal age. Signed informed consent prior to surgery. Willing to complete all follow-up requirements. Exclusion Criteria: Pregnant or nursing women. Have already had a valve replaced other than the aortic valve. Needs another valve replaced. Cannot return for required follow-up visits. Have active endocarditis. Acute preoperative neurological event (such as a stroke). Renal dialysis. History of substance abuse within one year, or a prison inmate. Participating in another study. Life expectancy less than two years.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trifecta Aortic Heart Valve<br>All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve. | Device: Trifecta Aortic Heart Valve<br>* Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Adverse Event Rates | 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] | Events occurring greater than or equal to 31 days post-implant. | 
| 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. | 1 year | 
| Characterize 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation