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Completed

NCT Number: NCT02663375

ACURATE TA™ Valve Implantation Registry: SAVI 2

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel, Vienna, Austria

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About this study

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.

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 all-cause mortality at 30 days follow-up

    Time frame: 30-Day Follow-up

    Rate of all-cause mortality at 30 days follow-up

Secondary outcomes

  1. Rate of clinical endpoints (VARC II) at 30 days and 12 months

    Time frame: 30-Days and 12 Months Follow-up

    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

  2. Procedural success post-implant

    Time frame: Procedure to 24h Post-implantation

    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

  3. Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up

    Time frame: 7-Days Follow-up and 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

  4. Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months

    Time frame: 30-Day and 12-Month Follow-up

    Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up.

Sponsors and collaborators

Lead sponsor

Symetis SA

Industry

Registry information

Official study title

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

Acronym: TA-SAVI2

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 26, 2016
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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