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

Symptomatic Aortic Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143686
• Other study ID #: 2011-02
• Status: Completed
• First received: December 8, 2014
• Last updated: March 15, 2018
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: March 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Germany	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	Uniklinik Köln Herzzentrum	Köln
Germany	Herzzentrum Leipzig	Leipzig
Germany	Universitäts Medizin Mainz	Mainz
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Sana Herzchirurgie Stuttgart GmbH	Stuttgart
Italy	Policlinico s. Orsola-Malpighi	Bologna
Switzerland	Inselspital-Stiftung	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Countries where clinical trial is conducted

Argentina,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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