Kardium has announced the successful first-in-human study of its next generation Globe pulsed field system to treat atrial fibrillation (AF) using pulsed field ablation (PFA) therapy.
Working with Vivek Reddy (Mount Sinai Hospital, New York, USA), and Petr Neužil and Jan Petrů from (Na Homolce Hospital, Prague, Czech Republic), 38 patients were successfully treated, isolating 100% of the patients’ pulmonary veins using the Globe system.
The Globe system features the Globe catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver PFA energy to the heart to treat AF. The catheter uses contact sensing to determine which electrodes are in contact with cardiac tissue to help ensure therapy is delivered effectively to the heart.
In this study, patients with paroxysmal AF received pulmonary vein isolation (PVI) treatment in around 16 minutes. Patients with persistent AF received PVI treatment, and then the Globe PF system was used to create a high-definition map of the entire atrium using real-time 3D mapping capabilities. Using these maps, all of the patients with persistent AF received additional ablation of the posterior wall and several patients also received a mitral isthmus line, all using the same Globe catheter.
“PVI with the Globe PF system was very easy. I could quickly position the catheter in each pulmonary vein, ensure that the electrodes were in good contact, and then deliver pulsed field energy to isolate each vein safely and rapidly from one position,” said Reddy. “I also really liked the system’s flexibility in more complex cases. I could map the atrium and then deliver additional pulsed field lesions to isolate the posterior wall quickly and then create a mitral isthmus line.”
Kardium now plans to conduct a global pivotal clinical study of the Globe PF system in the USA, Canada, Germany, and the Czech Republic for the purpose of obtaining regulatory approval for commercial sales.