NCT05474092Recruiting
Aeson TAH System - Post-Market Clinical Follow-up Study
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 95 (estimated)
- First submitted
- 29 Jun 2021
- Start date
- 23 Nov 2021
- Primary completion date
- May 2028
- Lead sponsor
- Carmat SAS
- Diseases
- Heart failure
- NCT number
- NCT05474092
What you commit to
- Study type: Observational
- Planned participants: 95
- From 23 Nov 2021 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HZ Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.