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

Symetis SA250 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Symptomatic Aortic Stenosis

Interventions

ACURATE TA™ Transapical Aortic BioprosthesisDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (17)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RWTH Aachen

Aachen, Germany

Zentralklinik Bad Berka

Outcomes

Primary Outcomes

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.

Time frame: 30 days and 12 Months Follow-up

Secondary Outcomes

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

Time frame: 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.

Time frame: 30 days and 12 Months follow-up

Data from ClinicalTrials.gov

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