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

Completed

• Conditions: Symptomatic Aortic Stenosis

• Registration Number: NCT03143686
• Lead Sponsor: Symetis SA

Brief Summary

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.

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2012-12
• Study Completion: 2013-11
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant	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 Outcome Measures

Name	Time	Method
Device success at 30 days and 12 Months follow-up	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.
Procedural Success post-implantation (up to 24 hours after device implantation)	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

Trial Locations

Locations (17)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

RWTH Aachen; 🇩🇪 Aachen, Germany

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany

Kerckhoff Klinik Bad Nauheim; 🇩🇪 Bad Nauheim, Germany

Herz-und Gefäss-Klinik GmbH; 🇩🇪 Bad Neustadt, Germany

Schüchtermann-Schiller'sche Kliniken GmbH; 🇩🇪 Bad Rothenfelde, Germany

Herzzentrum Dresden Universitätsklinik; 🇩🇪 Dresden, Germany

Klinik für Tgorax und Gefässchirurgie; 🇩🇪 Essen, Germany

Universitäres Herzzentrum; 🇩🇪 Hamburg, Germany

Klinik für Herzchirurgie; 🇩🇪 Karlsruhe, Germany

Scroll for more (7 remaining)