ACURATE TA™ Valve Implantation Registry: SAVI 2

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 collect continued surveillance data pertaining to safety and performance of the device.

Detailed Description
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The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™. The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open surgery is considered to be associated with high surgical risk. The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.

Official Title
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Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry

Conditions
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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 Biorposthesis<br>Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System | 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 all-cause mortality at 30 days follow-up | Rate of all-cause mortality at 30 days follow-up | 30-Day Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical endpoints (VARC II) at 30 days and 12 months | Rate of clinical endpoints (VARC II) at 30 days and 12 months: Mortality Stroke Myocardial infarction Bleeding complication Acute kidney injury Vascular complication Conduction disturbances and arrhythmia Other TAVI-related complications | 30-Days and 12 Months Follow-up | 
| Procedural success post-implant | Procedural success post-implant defined as ACURATE TA™ implanted in intended location with the following criteria: Insufficiency < +3 Mean aortic gradient < 20 mmHg EOA ≥ 1.0 cm2 No valve-in-valve or conversion to surgery performed | Procedure to 24h Post-implantation | 
| Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up | Device success analyzed by ECHO measurement at 7 days or discharge (whichever occurs first) and at 12 months follow-up and defined as the following criteria: ACURATE TA™ implanted in intended location No impingement of the mitral valve Normal coronary blood flow Valve-in-valve insufficiency < +3 Mean gradient < 20mmHg EOA ≥ 1.0 cm2 No valve-in-valve or conversion to surgery performed | 7-Days Follow-up and 12-Months Follow-up | 
| Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months | Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up. | 30-Day and 12-Month Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Aortic Stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transapical Access