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Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure — EFICAS  

Advanced Heart Failure Clinical Trial

Official title:
Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation

Clinical Trial Summary

The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.

Clinical Trial Description

A selection committee (composed of two independent experts in the field of cardiovascular surgery/cardiology and of PIs) assess the subject eligibility based on clinical and anatomic criteria. Clinically eligible patients will be distributed into two cohorts depending on their anatomic compatibility with the device: - cohort 1: patients that are anatomically compatible will receive the Carmat TAH ; - cohort 2: patients that are not anatomically compatible will receive standard therapy The efficacy and safety of the Carmat TAH will be assessed in cohort 1 and compared to a level of efficacy defined by the published data on the commercially available TAH; and adjusted for INTERMACS patient profile. The clinical utility and the costs of Carmat TAH will be assessed by comparing the cohort of subject receiving the Carmat TAH to the cohort of patients treated by standard therapy ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04475393
Study type Interventional
Source Carmat SA
Contact Soumia Aoualli
Phone +33 63 826 5953
Email clinique@carmatsas.com
Status Recruiting
Phase N/A
Start date December 12, 2022
Completion date April 2027
View Details
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