ACURATE TA™ Valve Implantation Registry: SAVI 2
NCT02663375 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2018-03-19
Summary
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
Conditions
- Aortic Stenosis
Interventions
- DEVICE
-
ACURATE TA™ Transapical Aortic Bioprosthesis
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.
Sponsors & Collaborators
-
Symetis SA
lead INDUSTRY
Principal Investigators
-
Thomas Walther, Professor · Kerckhoff Klinik
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-30
- Primary Completion
- 2015-01-31
- Completion
- 2016-01-31
Countries
- Austria
- Germany
- Italy
- Switzerland
Study Locations
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