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Aeson TAH System - Post-Market Clinical Follow-up Study

RECRUITINGSponsored by Carmat SAS
Actively Recruiting
SponsorCarmat SAS
Started2021-11-23
Est. completion2028-05
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05474092

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseHeart Failure

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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