Post-market follow-up for the Aeson Total Artificial Heart system
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
This study is testing how safe and effective the Aeson Total Artificial Heart is for patients after it has been approved for use, focusing on their survival and health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carmat SAS Industry-sponsored |
| Locations | 1 site (Dresden) |
| Trial ID | NCT05474092 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and performance of the Aeson Total Artificial Heart (TAH) system in routine clinical practice following its CE mark approval. The primary objective is to assess the survival rate of patients implanted with the device at 90 days post-implantation. Secondary objectives include monitoring survival rates at various intervals, evaluating health status changes, and assessing the safety profile of the device both pre- and post-transplantation. The study will also analyze the effectiveness of device upgrades and the incidence of serious adverse events.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are intended to receive the Aeson TAH system as part of their standard medical care.
Not a fit: Patients who are part of vulnerable populations and cannot provide voluntary consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the Aeson TAH system, potentially improving outcomes for patients with advanced heart failure.
How similar studies have performed: Other studies involving total artificial hearts have shown promising results, indicating that this approach is supported by prior successful outcomes.
Eligibility criteria
Show full inclusion / exclusion 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 not voluntarily consent to participate in the study
Where this trial is running
Dresden
- HZ Dresden — Dresden, Germany (Recruiting)
Study contacts
- Study coordinator: Elisabeth Vacher
- Email: Elisabeth.Vacher@carmatsas.com
- Phone: +33 6 34 92 86 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.