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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Aortic Stenosis
• Intervention / Treatment: Device: ACURATE TA™ Transapical Aortic Bioprosthesis

Detailed Description

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 (Actual): 250

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 4190
    • Hospital Italiano de Buenos Aires
• Germany
  • Aachen, Germany, 52074
    • RWTH Aachen
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik Bad Nauheim
  • Bad Neustadt, Germany, 97616
    • Herz-und Gefäss-Klinik GmbH
  • Bad Rothenfelde, Germany, 49214
    • Schüchtermann-Schiller'sche Kliniken GmbH
  • Dresden, Germany, 01307
    • Herzzentrum Dresden Universitätsklinik
  • Essen, Germany, 45122
    • Klinik für Tgorax und Gefässchirurgie
  • Hamburg, Germany, 20251
    • Universitäres Herzzentrum
  • Karlsruhe, Germany, 76185
    • Klinik für Herzchirurgie
  • Köln, Germany, 50937
    • Uniklinik Köln Herzzentrum
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig
  • Mainz, Germany, 55131
    • Universitäts Medizin Mainz
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg
  • Stuttgart, Germany, 70174
    • Sana Herzchirurgie Stuttgart GmbH
• Italy
  • Bologna, Italy, 40138
    • Policlinico S. Orsola-Malpighi
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital-Stiftung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ACURATE TA™ is approved for use to treat patients with severe aortic stenosis. The registry includes all comer patients following the Instructions For Use.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACURATE TA™ Transapical Aortic Bioprosthesis; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Symetis SA

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Severe symptomatic Aortic Stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2011-02