NCT05474092 Aeson TAH System - Post-Market Clinical Follow-up Study
| NCT ID | NCT05474092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carmat SAS |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 95 participants |
| Start Date | 2021-11-23 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 95 participants in total. It began in 2021-11-23 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05474092 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05474092 currently recruiting?
Yes, NCT05474092 is actively recruiting participants. Contact the research team at Elisabeth.Vacher@carmatsas.com for enrollment information.
Where is the NCT05474092 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT05474092 clinical trial?
NCT05474092 is sponsored by Carmat SAS. The trial plans to enroll 95 participants.
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