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Clinical Trials in Germany / NCT05474092
Recruiting Observational

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

NCT05474092 · tracked via the Priya Life Science Germany tracker
Sponsor
Carmat SAS
Phase
Observational
Started
2021-11-23
Last updated
2026-01-28

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Aeson Total Artificial Heart

Aeson Total Artificial Heart: Heart Replacement Therapy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Survival rate — 90 days post-implant
    Proportion of patients surviving on the originally implanted Aeson device (superiority test \> 64%)

Trial sites (1)

FacilityCityRegionStatus
HZ Dresden Dresden Germany Recruiting

Other trials for the same condition

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A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting
Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany Active, not recruiting
European Registry of Transcatheter Repair for Tricuspid Regurgitation Recruiting
A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05474092 on ClinicalTrials.gov ↗ ← All trials in Germany