CARMAT Obtains Approval to Resume PIVOTAL Study Implants in France

CARMAT, designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, has obtained ANSM (French agency for the safety of medicines and health products) and CPP Ouest III (ethics committee) approval to perform implants of its device within the framework of the PIVOTAL study in France.
 
These approvals open up the possibility for French patients to receive the CARMAT device and for French hospitals to contribute to the completion of enrollment in the PIVOTAL study by the end of the first quarter of 2021.
 
To date, the number of implants performed within the framework of the PIVOTAL study stands at 13, including 10 in the first cohort, now closed, and three in the second cohort, which is currently enrolling patients.
 
As a reminder, the study protocol provides for the enrollment of a total of 10 patients in the second cohort, and the primary endpoint of the study is six-month survival with the bioprosthesis or a successful heart transplant within six months of the device being implanted.
 
Stéphane Piat, CEO of CARMAT, said: “We are delighted to be able to resume implants of the CARMAT heart in France. The enrollment pace, impacted by the COVID-19 situation in the centers in the Czech Republic, Denmark and  Kazakhstan,  could  hence  accelerate with the participation of highly specialized French centers to complete this key study. This is also very important in view of the futureEFICAS study, insofar as the chosen French centers will thus be able to acquire valuable clinical experience before the launch of this broad study that is expected to begin in the second quarter of 2021. We are simultaneously working with centers in the United States to enable the U.S. early feasibility study (EFS) to begin before the end of the year, as planned.”
 
Professor Jean-François Obadia, head of the Cardiothoracic Surgery and Heart Transplant department at Louis Pradel hospital (CHU LYON) and the study’s national principal investigator, added: “Our participation in the PIVOTAL study will finally give us access to this technology that meets an urgent clinical need for which we so far had no satisfactory solution. The prosthesis’ performances observed in the first patients already implanted abroad and our recent experience during the training of our teams in France are very encouraging. We are delighted to have this opportunity, particularly as our teams will subsequently participate in the EFICAS study, supported by the French Ministry of Health and Solidarity.”