Aeson TAH System - Post-Market Clinical Follow-up Study
Recruiting
Observational Study
Heart Failure
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 95 (estimated)
- Sponsor
- Carmat SAS · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 no…
Contacts