Status:
COMPLETED
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Lead Sponsor:
Symetis SA
Conditions:
Aortic Stenosis
Eligibility:
All Genders
75+ years
Brief Summary
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosi...
Detailed Description
The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURAT...
Eligibility Criteria
Inclusion
- Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use
- Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Exclusion
- 1\. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02306226
Start Date
September 1 2014
End Date
April 1 2017
Last Update
March 19 2018
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