Overview
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.
Description
The Primary objective/endpoint is survival rate on the originally implanted Aeson device at 90 days post-implant (H1 > 64%).
The second objectives/endpoints are:
- Confirm the performance and safety profile of the device for patients implanted with the
Aeson TAH system until being transplanted:
- Survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation;
- Health status change as measured by NYHA classification, 6MWT and Quality of Life Questionnaire (EQ-5D-5L);
- Renal and hepatic function as measured by biological parameters;
- Hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events;
- Frequency and Incidence of Serious Adverse events.
- Assess the effectiveness of device upgrades
- Confirm the safety profile of the device for patients after being transplanted.
- Survival at 30 days, 6 months, and 12 months post-transplant
- Frequency and Incidence of Serious Adverse Event of special interest as graft reject, neurological events, major bleeding.
Eligibility
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