Aeson TAH System - Post-Market Clinical Follow-up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aeson Total Artificial Heart.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Overview
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.
Interventions
- Device Aeson Total Artificial Heart
Heart Replacement Therapy
Primary outcome measures
- Survival rate [Time frame: 90 days post-implant]
Secondary outcome measures (7)
- Survival and total support duration before transplantation [Time frame: 6, 12, 18 and 24-months post-implant]
- Health status change before transplantation [Time frame: 3, 6, 9, 12, 18 and 24-months post-implant]
- Functional status change before transplantation [Time frame: 3, 6, 9, 12, 18 and 24-months post-implant]
- Length of hospital stay and time at home before transplantation [Time frame: 3, 6, 9, 12, 18 and 24-months post-implant]
- Frequency and Incidence of Serious Adverse events before transplantation [Time frame: 3, 6, 9, 12, 18 and 24-months post-implant]
- Assess the effectiveness of device upgrades [Time frame: Between 3 and 24 months post-implantation, when heart transplant occurred]
- Confirm the safety profile of the device after transplantation [Time frame: 30 days, 3 months, 6 months, 12 months post-transplantation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- HZ Dresden — Dresden
Identifiers
NCT: NCT05474092 · CAR2021-PM