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OpenTrials
Completed

NCT Number: NCT03143686

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

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.

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Key information

Conditions

Symptomatic Aortic Stenosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACURATE TA™ Transapical Aortic Bioprosthesis

Device

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.

Other names: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System

Primary outcomes

  1. Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant

    Time frame: 30 days and 12 Months Follow-up

    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.

Secondary outcomes

  1. Procedural Success post-implantation (up to 24 hours after device implantation)

    Time frame: 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

  2. Device success at 30 days and 12 Months follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Symetis SA

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 8, 2017
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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