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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Aeson Total Artificial Heart

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 Type: Observational
• Enrollment (Estimated): 95

Contacts and Locations

• Study Contact: Name: Elisabeth Vacher; Phone Number: +33 6 34 92 86 84; Email: Elisabeth.Vacher@carmatsas.com
• Study Contact Backup: Name: Piet Jansen; Phone Number: +33 6 46 06 07 12; Email: piet.jansen@carmatsas.com

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • HZ Dresden
    • Contact: Manuel Wilbring; Phone Number: +49 351 450 25141; Email: Manuel.Wilbring@herzzentrum-dresden.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients intended to receive Aeson TAH system as per commercial use

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Proportion of patients surviving on the originally implanted Aeson device (superiority test > 64%)	90 days post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival and total support duration before transplantation	Survival post-implant	6, 12, 18 and 24-months post-implant
Health status change before transplantation	Measured by EuroQol EQ-5D-5L questionnaire, health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (EQ-5D-5L). The responses record five levels of severity (1:no problems; 2:slight problems; 3:moderate problems 4:severe problems; 5:extreme problems) within a particular EQ-5D dimension	3, 6, 9, 12, 18 and 24-months post-implant
Functional status change before transplantation	Measured by 6 minutes walking distance in meters	3, 6, 9, 12, 18 and 24-months post-implant
Length of hospital stay and time at home before transplantation	Measured with discharge timing, frequency and duration of rehospitalizations; time at home or rehabilitation site	3, 6, 9, 12, 18 and 24-months post-implant
Frequency and Incidence of Serious Adverse events before transplantation	As defined by INTERMACS	3, 6, 9, 12, 18 and 24-months post-implant
Assess the effectiveness of device upgrades	Standard expertise of explanted device	Between 3 and 24 months post-implantation, when heart transplant occurred
Confirm the safety profile of the device after transplantation	Survival after transplantation	30 days, 3 months, 6 months, 12 months post-transplantation

Collaborators and Investigators

• Sponsor: Carmat SAS

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Total Artificial Heart; Advanced Heart Failure; Bridge to Transplant
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CAR2021-PM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No