Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05474092
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.
Study:
NCT05474092
Study Brief:
Protocol Section:
NCT05474092