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

NCT ID: NCT03143686

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-11-30

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.

Conditions

Symptomatic Aortic Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ACURATE TA™ Transapical Aortic Bioprosthesis

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symetis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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 an der Saale, , Germany

Schüchtermann-Schiller'sche Kliniken GmbH

Bad Rothenfelde, , Germany

Uniklinik Köln Herzzentrum

Cologne, , Germany

Herzzentrum Dresden Universitätsklinik

Dresden, , Germany

Klinik für Tgorax und Gefässchirurgie

Essen, , Germany

Universitäres Herzzentrum

Hamburg, , Germany

Klinik für Herzchirurgie

Karlsruhe, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

Universitäts Medizin Mainz

Mainz, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Sana Herzchirurgie Stuttgart GmbH

Stuttgart, , Germany

Policlinico s. Orsola-Malpighi

Bologna, , Italy

Inselspital-Stiftung

Bern, , Switzerland

Countries

Argentina; Germany; Italy; Switzerland

Other Identifiers

2011-02

Identifier Type: -

Identifier Source: org_study_id