RecruitingNCT05474092
Aeson TAH System - Post-Market Clinical Follow-up Study
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Sponsor
Carmat SAS
Enrollment
95 participants
Start Date
Nov 23, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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
- Vulnerable populations who could not voluntarily consent to participate in the study
Interventions
DEVICEAeson Total Artificial Heart
Heart Replacement Therapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05474092
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