The third CARMAT heart implanted patient died on December 18, nearly nine months after his operation. A death that does not sign the end of the clinical trial.
The third patient implanted with a CARMAT prosthesis died on December 18, 2015 in the morning, announces the French designer of the artificial heart. “This is a sudden death by respiratory arrest during chronic renal failure”, indicates the company which specifies that the prosthesis is not involved in the death of the patient.
The 74-year-old man had been operated on on April 8, 2015. After 4 months of hospitalization, he was able to return home. He suffered from severe pathologies, in particular renal failure, which pre-existed the implantation. Thanks to the artificial heart, this terminally ill patient with heart failure was able to live 8 more months.
The continuation of the clinical trial
A fourth patient should be included in this clinical feasibility trial. The initial protocol made it possible to include only patients not eligible for transplantation in the terminal phase of irreversible biventricular heart failure. “From now on, the criterion related to the stage of heart failure has been relaxed so that a greater number of patients can benefit from the CARMAT heart. Patients eligible for transplantation, under certain conditions, may also be included in the study. “
The expansion of recruitment criteria was made possible thanks to data from the first two locations. Authorization from the National Medicines Safety Agency (ANSM) and the Personal Protection Committee (CPP) also follows the expert report submitted by the company. This proposed the solutions implemented to correct the anomalies of the prosthesis. “Prostheses intended for future implantations will have these modifications,” says CARMAT.
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