NCT02962973

European Clinical Evaluation of the Carmat Total Artificial Heart

Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Carmat SAS · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support. Each subject receiving the Carmat TAH will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years. The results of the study will be used to support a CE mark application.

Detailed description

Center selection is based on the following: experience with VAD/TAH implantation and record of good results in this patient population (% of survival), the infrastructure required to perform the clinical investigation (especially the surgical and cardiology teams); site resources and experience to manage the clinical study and the patient population; the adherence to the standards of Good Clinical Practice. A specific focus during the site selection is done on dedicated VAD - nurse team to ensure that: * Sites are experienced in the selection of patients whom require a mechanical circulatory support. Social and psychological conditions of the patient and family must be considered to ensure patient and family commitment in the care pathway, * Close supervision of patients on the use of the device (when changing batteries) by experienced hospital professionals is guarantee; * Extensive hospital training program and regular support for patients and family - relatives are ensured.

Conditions

• Advanced Heart Failure

Interventions

Type	Name	Description
DEVICE	CARMAT TAH
PROCEDURE	Surgical intervention

Timeline

• Start date: 2016-09-01
• Primary completion: 2025-12-01
• Completion: 2026-07-01
• First posted: 2016-11-15
• Last updated: 2025-02-14

Locations

2 sites across 2 countries: Kazakhstan, Netherlands