Prof. Alain Carpentier, designer of the bioprosthetic heart and co-founder of the Carmat company, told Quotidien du Médecin in an interview that “an authorization request will be made to resume clinical trials on the artificial heart and that the conclusions should not be be made public only after the 4 tests ”.
The first implanted patient died on March 2, 75 days after his heart transplant. For this first test, the researchers had set a period of 30 days before being able to say that it was conclusive. A major step forward, but the patient’s artificial heart suddenly stopped on the 75th day.
“The first implantation being conclusive, the Carmat company, as promoter of the clinical study, will in fact request an authorization for the resumption of inclusions from the National Medicines Safety Agency, ANSM and the committee for the protection of people (CPP) who expresses themselves on the ethical aspects of experiments) ”, Professor Carpentier told Le Quotidien du Médecin.
However, the professor does not give dates or an explanation of the causes of the death of the first patient to be transplanted. “The clinical trial involves four patients. The conclusions of this test will be communicated in compliance with the regulations in force. It is very unusual to report the results of a trial patient by patient ”.
Hope for the sick
The artificial heart of the Carmat company is a real hope for patients suffering from heart failure. This cardiovascular disorder makes it impossible for the heart to contract enough to send the volume of blood sufficient to supply the whole body. People who suffer from it are constantly short of breath, tired and sometimes need to be hospitalized. In France, heart failure is responsible for more than 32,000 deaths each year.
This “definitive total artificial heart is not intended to replace heart transplants but to complete them by compensating for the lack of grafts and by responding to patients who are not eligible for transplantation”, recalls Pr Carpentier.
