Trifecta™ GT Post Market Clinical Follow-up

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

Detailed Description
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The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide. Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.

Official Title
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Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

Conditions
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Aortic Valve Disease, Aortic Valve Disorder

Intervention / Treatment
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* Device: Trifecta GT (Glide Technology) Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve. Subject is of legal age in the country where the subject is enrolled. Subject must be willing and able to provide written informed consent to participate in this study. Subject must be willing and able to comply with all follow-up requirements. Exclusion Criteria: Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery. Subject has contraindication for cardiac surgery. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians. Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery). Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery. Subject is undergoing renal dialysis. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery. Subject has a left ventricular ejection fraction < 30%. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study). Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. Subject has a life expectancy less than 2 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>All subjects will receive the Trifecta GT valve | Device: Trifecta GT (Glide Technology) Valve<br>* Surgical aortic valve replacement with Trifecta GT Valve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from surgical valve replacement or transcatheter valve-in-valve implantation | Determined by adverse event reporting | 5 years post implant |