Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05474092

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

Sponsor: Carmat SAS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

95

Start Date

2021-11-23

Completion Date

2030-05

Last Updated

2026-01-28

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Aeson Total Artificial Heart

Heart Replacement Therapy

Locations (1)

HZ Dresden

Dresden, Germany