Vancouver, British Columbia-based Kardium recently received FDA investigational device exemption (IDE) to conduct the study. The international, multicenter PULSAR study evaluates the safety and effectiveness of Globe PF for the treatment of AFib using PFA.
The study also received Health Canada approval and SUKL approval in the Czech Republic, according to a news release.
Kardium said it expects the PULSAR study to enroll more than 400 patients across up to 35 sites. These sites range between the U.S., Canada and Europe. Dr. Vivek Reddy (Mt. Sinai Hospital, New York) and Dr. Atul Verma (McGill University Health Centre, Montreal) are principal investigators. Dr. Reddy, Prof. Petr Neužil and Dr. Jan Petru treated the first patients this week at Na Homolce Hospital.
“From our experience with the PULSE-EU study, we have found the Globe System can provide a rapid and durable treatment of AFib and has so far demonstrated exceptional rates of effectiveness,” Reddy said. “I am excited to begin treating patients in the PULSAR IDE study.”
About the Kardium Globe PF system
The company said its study expands on its successful first-in-human trial of 69 patients. Initial results demonstrated 100% acute pulmonary vein isolation (PVI) and 100% durable isolation at three-month remapping. Patients in the trial received an optimized PFA dose.
Globe PF features Kardium’s Globe catheter with 122 gold electrodes. Each electrode can map the patient’s cardiac anatomy and electrical activity and deliver PF energy to the heart. Globe catheter sensors provide proprietary Contact maps to identify electrodes in contact with cardiac tissue. This helps to ensure therapy for AFib is effectively delivered.
“The whole team at Kardium is thrilled to be starting the PULSAR study,” said Kardium CEO Kevin Chaplin. “We believe the Globe system has the potential to improve outcomes for patients with atrial fibrillation, while also making the procedures easier for physicians.”