Aeson TAH System - Post-Market Clinical Follow-up Study
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.
detailed 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:
1. 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. 2. Assess the effectiveness of device upgrades 3. 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.
official title
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting