Kardium has announced today that the first US patients have been successfully treated in the PULSAR clinical study, using its Globe pulsed-field ablation system.
The PULSAR study will enrol over 400 patients for treatment at up to 35 sites in the USA, Canada, and Europe. The first US patients were treated this week at Mount Sinai Hospital by Vivek Reddy (Mount Sinai Hospital, New York, USA), who is a principal investigator in the trial alongside Atul Verma (McGill University Health Centre, Montreal, Canada).
The study expands on the successful Globe System PULSE-EU study of 69 patients treated in Prague, Czech Republic. Results of the PULSE-EU study were recently presented at the Heart Rhythm Society (HRS) annual meeting (19–21 May, New Orleans, USA). The results showed that 100% of veins were acutely isolated, with an average of 22.5 minutes required to isolate all veins. At three-month remapping, 96% of veins were still durably isolated in patients with paroxysmal AF. No oesophageal or brain lesions were identified in these patients.
“As a next generation pulsed field system, the Globe system allows precise delivery of pulsed field energy. Clinical results have shown rapid and durable PV isolation and have so far demonstrated high rates of effectiveness,” said Reddy. “I am excited to be starting the US phase of the PULSAR study here at Mount Sinai.”
“This is a very important milestone for Kardium, as we start the US phase of the PULSAR study,” said Kardium CEO Kevin Chaplin. “We believe the Globe system has the potential to improve outcomes for patients with atrial fibrillation. We look forward to replicating the outstanding results from our PULSE-EU study, here in the US.”
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 pulsed field energy to the heart. The Globe catheter sensors are used to create a proprietary Contact Map to identify electrodes in contact with cardiac tissue, helping ensure that therapy for atrial fibrillation is effectively delivered.
The PULSAR clinical study is a US Food and Drug Administration (FDA) investigational device exemption (IDE) study that will be used to validate the safety and effectiveness of the Globe system for regulatory approval and commercial sale.