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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474092
• Other study ID #: CAR2021-PM
• Status: Recruiting
• Start date: November 23, 2021
• Est. completion date: November 2026

Study information

• Verified date: June 2024
• Source: Carmat SA
• Contact: Elisabeth Vacher
• Phone: +33 6 34 92 86 84
• Email: Elisabeth.Vacher[@]carmatsas.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: November 2026
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Aeson Total Artificial Heart
Heart Replacement Therapy

Locations

Country	Name	City	State
Germany	HZ Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Carmat SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Proportion of patients surviving on the originally implanted Aeson device (superiority test > 64%)	90 days post-implant
Secondary	Survival and total support duration before transplantation	Survival post-implant	6, 12, 18 and 24-months post-implant
Secondary	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
Secondary	Functional status change before transplantation	Measured by 6 minutes walking distance in meters	3, 6, 9, 12, 18 and 24-months post-implant
Secondary	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
Secondary	Frequency and Incidence of Serious Adverse events before transplantation	As defined by INTERMACS	3, 6, 9, 12, 18 and 24-months post-implant
Secondary	Assess the effectiveness of device upgrades	Standard expertise of explanted device	Between 3 and 24 months post-implantation, when heart transplant occurred
Secondary	Confirm the safety profile of the device after transplantation	Survival after transplantation	30 days, 3 months, 6 months, 12 months post-transplantation