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

Recruiting now

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT05474092

Run by

Carmat SAS

People needed

95

Starts

2021-11-23

Expected to finish

2030-05-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

• HZ Dresden — Dresden, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.