Follow-up study of the Aeson artificial heart in people with heart failure
Checks safety and performance of the Aeson artificial heart in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Aeson TAH System - Post-Market Clinical Follow-up Study
Key facts
- Where
- Dresden, GermanySee the site
Where in Germany
- HZ DresdenDresden, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Carmat SAS
- Trial code
- NCT05474092
- Record updated
- 28 January 2026
- Original description
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.Read full original descriptionShow less
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
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.
Inclusion: Patient is intended to receive an Aeson TAH system according to the IFU indications within standard medical practice; Patient has provided written informed consent using the Ethics Committee approved consent form; Non-inclusion Criteria:; Vulnerable populations who could not voluntarily consent to participate in the study.