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

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.

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