PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
NCT02987894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2020-04-09
Summary
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
Conditions
- Aortic Stenosis
Interventions
- DEVICE
-
ACURATE neo™ Aortic Bioprosthesis
TAVI, transcatheter aortic valve replacement. Transfemoral access.
Sponsors & Collaborators
-
Symetis SA
lead INDUSTRY
Principal Investigators
-
Won-Keun Kim, Dr · Kerckhoff-Klinik Forschungsgesellschaft mbH
Eligibility
- Min Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-02
- Primary Completion
- 2019-09-30
- Completion
- 2019-09-30
Countries
- Canada
- Germany
- Italy
- United Kingdom
Study Locations
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