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RECRUITING
NCT05474092
Aeson TAH System - Post-Market Clinical Follow-up Study
Sponsor: Carmat SAS
View on ClinicalTrials.gov
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.
Official title: Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
95
Start Date
2021-11-23
Completion Date
2030-05
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
DEVICE
Aeson Total Artificial Heart
Heart Replacement Therapy
Locations (1)
HZ Dresden
Dresden, Germany