Medtronic has announced the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect pulsed field ablation (PFA) system, a novel, breakthrough technology that uses pulsed electric fields to treat atrial fibrillation (AF).
The first procedure in the PULSED AF pivotal trial was performed this week at Southcoast Health by Nitesh Sood, Fall River, USA; the second procedure was performed by Arnoldas Giedrimas, also at Southcoast Health. The PULSED AF Trial is the first global, premarket, multicentre clinical study with IDE approval aimed to establish the safety and efficacy of the PulseSelect system.
The PulseSelect System delivers pulsed electric fields through an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that trigger atrial fibrillation. However, unlike traditional methods of ablation that heat (radio frequency ablation) or cool (cryoablation) the atrial tissue, the PulseSelect system uses a non-thermal approach and preferentially targets heart tissue with the goal of avoiding unwanted injury to surrounding structures, a risk of current ablation technologies.
“Based on the results we’ve experienced with the pilot trial, we are entering a new era for AF ablation techniques with this novel energy source,” said Atul Verma, electrophysiologist and head of arrhythmia services at Southlake Regional Health Centre in Newmarket, Canada and the principal investigator (PI) for the PULSED AF study. “We are excited to begin the pivotal stage of the PULSED AF study and generate a larger body of clinical evidence to support the safety and benefits of pulsed field ablation.”
The PULSED AF trial is a prospective, non-randomised, multicentre clinical trial that will enrol up to 500 patients who will be treated with the PulseSelect system across as many as 50 sites in the USA, Canada, Europe, and Australia. PULSED AF is designed to evaluate the safety and efficacy of the PulseSelect System for the treatment of AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF. Patients will be assessed at six and 12 months.
“For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed field ablation,” said Rob Kowal, chief medical officer of Cardiac Ablation Solutions, which is reported as part of the Cardiac and Vascular Group at Medtronic. “Developed internally at Medtronic, the PulseSelect System has the potential to create a paradigm shift in how cardiac ablations are performed for patients suffering from atrial fibrillation.”
Pre-clinical research on the PulseSelect technology has included work to understand the physiology and mechanism of action for this novel energy source, resulting in its designation in 2018 as a Breakthrough Device from the US Food and Drug Administration (FDA) for the treatment of drug refractory recurrent symptomatic atrial fibrillation. PulseSelect was designated with Innovative Device Status, also known as Green Channel, in November 2020 by the Center for Medical Device Evaluation (CMDE), the arm of the National Medical Products Administration (NMPA) that sets medical device regulations for China.
Results of the PULSED AF pilot study were presented in a late-breaking session at Heart Rhythm Society 2020 Science and additional evidence was shared at the AF Symposium in January 2021, demonstrating 100% acute efficacy and no device or procedural-related events in the pilot cohort of patients. Worldwide, the PulseSelect system is investigational and not approved for sale or distribution.