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

Heart Failure Clinical Trial

Official title: Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT05474092
• Study type: Observational
• Source: Carmat SA
• Contact: Elisabeth Vacher
• Phone: +33 6 34 92 86 84
• Email: Elisabeth.Vacher@carmatsas.com
• Status: Recruiting
• Start date: November 23, 2021
• Completion date: November 2026