ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

Study Overview
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Brief Summary
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Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

Detailed Description
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A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.

Conditions
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Symptomatic Aortic Stenosis

Intervention / Treatment
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* Device: ACURATE TA™ Transapical Aortic Bioprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has severe aortic stenosis Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm Patient willing to participate in the study and provides signed EC-approved informed consent The subject and treating physician agree the subject will return for all required post-procedure follow-up visits Exclusion Criteria: Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
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 |
| --- | --- |
| ACURATE TA™ Transapical Aortic Bioprosthesis<br>The first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted. | Device: ACURATE TA™ Transapical Aortic Bioprosthesis<br>* ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.<br>* Other names: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant | Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant . MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke. | 30 days and 12 Months Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success post-implantation (up to 24 hours after device implantation) | Procedural success defined as successful ACURATE TA™ implantation at intended site and adequate device functioning immediately post-implantation and without intra-procedural mortality | Post-Implantation (up to 24 hours after device implantation) | 
| Device success at 30 days and 12 Months follow-up | Device success at 30 day and 12 month follow-up visit defined as adequate functioning of the ACURATE TA™ as confirmed by echocardiography. | 30 days and 12 Months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe symptomatic Aortic Stenosis