Clinical trial NCT05474092: Aeson TAH System - Post-Market Clinical Follow-up Study
Official title: Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Advanced Heart Failure
Total Artificial Heart
Bridge to Transplant
Lead sponsor: Carmat SA
Sponsor class: INDUSTRY
First posted: 2022-07-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intended to receive Aeson TAH system as per commercial use

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.

Eligibility 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

Primary outcomes:
measure: Survival rate
timeFrame: 90 days post-implant
Secondary outcomes:
measure: Survival and total support duration before transplantation
timeFrame: 6, 12, 18 and 24-months post-implant
measure: Health status change before transplantation
timeFrame: 3, 6, 9, 12, 18 and 24-months post-implant
measure: Functional status change before transplantation
timeFrame: 3, 6, 9, 12, 18 and 24-months post-implant
measure: Length of hospital stay and time at home before transplantation
timeFrame: 3, 6, 9, 12, 18 and 24-months post-implant
measure: Frequency and Incidence of Serious Adverse events before transplantation
timeFrame: 3, 6, 9, 12, 18 and 24-months post-implant
measure: Assess the effectiveness of device upgrades
timeFrame: Between 3 and 24 months post-implantation, when heart transplant occurred
measure: Confirm the safety profile of the device after transplantation
timeFrame: 30 days, 3 months, 6 months, 12 months post-transplantation
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: HZ Dresden
Study officials:
References: