NCT05474092

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
49mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Nov 2021May 2030

First Submitted

Initial submission to the registry

June 29, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 23, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6.4 years

First QC Date

June 29, 2021

Last Update Submit

January 27, 2026

Conditions

Heart Failure

Keywords

Advanced Heart FailureTotal Artificial HeartBridge to Transplant

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    Proportion of patients surviving on the originally implanted Aeson device (superiority test \> 64%)

    90 days post-implant

Secondary Outcomes (7)

  • Survival and total support duration before transplantation

    6, 12, 18 and 24-months post-implant

  • Health status change before transplantation

    3, 6, 9, 12, 18 and 24-months post-implant

  • Functional status change before transplantation

    3, 6, 9, 12, 18 and 24-months post-implant

  • Length of hospital stay and time at home before transplantation

    3, 6, 9, 12, 18 and 24-months post-implant

  • Frequency and Incidence of Serious Adverse events before transplantation

    3, 6, 9, 12, 18 and 24-months post-implant

  • +2 more secondary outcomes

Interventions

Aeson Total Artificial HeartDEVICE

Heart Replacement Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients intended to receive Aeson TAH system as per commercial use

You may qualify if:

  • 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
  • Vulnerable populations who could not voluntarily consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HZ Dresden

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Elisabeth Vacher

CONTACT

+33 6 34 92 86 84Elisabeth.Vacher@carmatsas.com

Piet Jansen

CONTACT

+33 6 46 06 07 12piet.jansen@carmatsas.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 26, 2022

Study Start

November 23, 2021

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

DE(1)