Trifecta™ Durability Study

Study Overview
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Brief Summary
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The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.

Official Title
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Trifecta™ Durability Study

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Trifecta™ aortic bioprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines Patient requires aortic valve replacement. Patient is legal age in host country. Patients must be able and willing to provide written informed consent to participate in this investigation Patients must be willing and able to comply with all follow-up requirements Exclusion Criteria: Patients with contraindication for cardiac surgery Patients who are pregnant. Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits. Patient has active endocarditis Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery. Patient is undergoing renal dialysis. Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate. Patient has a documented thrombus in left atrium or left ventricle. Patient had in the past mitral or tricuspid valve replacement. Patient needs mitral and/or tricuspid valve replacement. Patient has an Ejection Fraction < 25% Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. Patient has a 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trifecta™ Valve Group<br>Subjects implanted with the Trifecta™ aortic bioprosthesis. | Device: Trifecta™ aortic bioprosthesis<br>* Surgical aortic valve replacement with the Trifecta™ valve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuarial Freedom From Reintervention Due to Structural Valve Deterioration | Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuarial Freedom From All-cause Mortality | Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator. | 10 years | 
| Freedom From Valve Related Mortality | Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality. | 10 years | 
| Freedom From Structural Valve Deterioration | Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation. | 10 years |