Aeson TAH System - Post-Market Clinical Follow-up Study
Recruiting · NCT05474092 · Observational (researchers observe without assigning treatment) · Lead sponsor: Carmat SAS
View the official record on ClinicalTrials.gov →Interventions studied
Aeson Total Artificial Heart
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Where it is running
1 location listed.
- HZ Dresden - Dresden, Germany