Aeson TAH System - Post-Market Clinical Follow-up Study
NCT05474092 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 95
Last updated 2026-01-28
Summary
The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the Aeson TAH system when used in routine care by surgeons.
Conditions
Interventions
- DEVICE
-
Aeson Total Artificial Heart
Heart Replacement Therapy
Sponsors & Collaborators
-
Carmat SAS
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-23
- Primary Completion
- 2028-05-31
- Completion
- 2030-05-31
Countries
- Germany
Study Locations
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