Brief Title
ACURATE TA™ Valve Implantation Registry: SAVI 2
Official Title
Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
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 collect continued surveillance data pertaining to safety and performance of the device.
Detailed Description
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Rate of all-cause mortality at 30 days follow-up
Secondary Outcome
Rate of clinical endpoints (VARC II) at 30 days and 12 months
Condition
Aortic Stenosis
Intervention
ACURATE TA™ Transapical Aortic Bioprosthesis
Study Arms / Comparison Groups
ACURATE TA™ Transapical Aortic Biorposthesis
Description: Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
250
Start Date
November 2013
Completion Date
January 2016
Primary Completion Date
January 2015
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Walther, Professor, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02663375
Organization ID
2013-04
Responsible Party
Sponsor
Study Sponsor
Symetis SA
Study Sponsor
Thomas Walther, Professor, Principal Investigator, Kerckhoff Klinik
Verification Date
March 2018