Brief Title
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Official Title
Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry
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 stenosis treated with the commercialized device
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 ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System. The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device. The secondary objective is to evaluate adverse events and device performance of the newly marketed device.
Study Type
Observational [Patient Registry]
Primary Outcome
Rate of all-cause mortality
Condition
Aortic Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
September 2014
Completion Date
April 2017
Primary Completion Date
May 2016
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry 3. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits Exclusion Criteria: 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.
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Helge Möllmann, Prof., ,
Administrative Informations
NCT ID
NCT02306226
Organization ID
2013-05
Responsible Party
Sponsor
Study Sponsor
Symetis SA
Study Sponsor
Helge Möllmann, Prof., Principal Investigator, Kerckhoff Klinik
Verification Date
March 2018