Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure
Objective(s) of the trial
The purpose of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in patients suffering from advanced heart failure and requiring biventricular support.
Each subject receiving the Carmat TAH is followed to the primary and secondary endpoints at 6 months, with a subsequent follow-up period extending to 2 years post implant.
The results of the study will be used to support a CE mark application.