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

Carmat SAS

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Aeson Total Artificial Heart

Study type: Observational

Funder types: Industry

Identifiers

NCT05474092

CAR2021-PM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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