Status:
TERMINATED
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
Lead Sponsor:
Symetis SA
Conditions:
Aortic Stenosis
Eligibility:
All Genders
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 bipros...
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...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
February 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03454360
Start Date
February 6 2018
End Date
April 30 2020
Last Update
December 11 2020
Active Locations (10)
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1
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
2
Herz-und Gefäß-Kilink GmbH
Bad Neustadt an der Saale, Germany, 97616
3
Krankenhausbetriebgesellschaft
Bad Oeynhausen, Germany, D-32545
4
BG Klinik Bergmannsheil
Bochum, Germany, 44789