Brief Title
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
Official Title
Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
Brief Summary
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System. Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population. As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.
Detailed Description
The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.
Study Type
Observational
Primary Outcome
All cause mortality
Secondary Outcome
Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
Condition
Aortic Stenosis
Intervention
ACURATE neo™ Aortic Bioprosthesis
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
107
Start Date
February 6, 2018
Completion Date
April 30, 2020
Primary Completion Date
April 30, 2020
Eligibility Criteria
Inclusion criteria: - Symptomatic patients with severe aortic stenosis; - Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate; Exclusion criteria: - Patients unable or unwilling to give inform consent;
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Michael Hilker, Prof.Dr.med, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03454360
Organization ID
2016-03
Responsible Party
Sponsor
Study Sponsor
Symetis SA
Study Sponsor
Michael Hilker, Prof.Dr.med, Principal Investigator, Universitätsklinikum Regensburg
Verification Date
December 2020