Pulse Select PFA system demonstrates impressive results in landmark PULSED AF global IDE trial;- Medtronic

PULSED AF exceeded the threshold for its efficacy performance goal and further, clinical success, freedom from recurrence of any symptomatic atrial arrhythmias, was at least 80% for each patient cohort. Findings from the PULSED AF Pivotal Trial were presented as a late-breaking trial at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.23/WCC) and simultaneously published in Circulation.

PULSED AF is the first and only completed, global, and multi-center clinical study with IDE approval to evaluate the safety and effectiveness of PFA technology for AF ablation. PFA is a breakthrough ablation technology that uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of patients with paroxysmal or persistent AF.

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. The trial is a prospective, single arm, multi-center clinical trial that treated 300 patients (150 with paroxysmal AF and 150 with persistent AF). Patients were enrolled across 41 sites in nine countries with 67 operators throughout the United States, Canada, Europe, Australia, and Japan.

Study Results: Safety :The study exceeded its performance goal of freedom from a composite of serious procedure and device-related adverse events with a 0.7% (p=0.002) rate of primary adverse events in both patient cohorts. There were no esophageal events, instances of pulmonary vein stenosis, or phrenic nerve injury.

"Uniquely, these results represent the first prospective, global, large-scale study with two different, rigorously monitored patient populations that demonstrates an impressively low adverse event rate of 0.7%," said Atul Verma, M.D., electrophysiologist and director, Division of Cardiology, McGill University Health Centre in Montreal and principal investigator (PI) for the PULSED AF study. "The results of PFA trials have been highly anticipated among the EP community to help us treat the growing number of AF patients around the world. The high rate of 80% or more in clinical success and the promising safety and efficiency results from PULSED AF will help establish PFA as an exciting new option for patients.".

Study Results: Efficacy : PULSED AF exceeded the threshold for efficacy performance at 66% efficacy in paroxysmal AF patients and 55% in persistent AF patients (p<0.001), based on the pre-specified performance goals of greater than 50% (paroxysmal) and graater than 55% (persistent) at 12 months. the pulsed af primary effectiveness endpoint included a composite of measures based on efficacy endpoints across multiple studies of radiofrequency (rf) and cryoablation energy sources. the composite endpoint included freedom from acute procedural failure, arrhythmia recurrence, repeat ablation, direct current cardioversion, left atrial surgery, or antiarrhythmic escalation through twelve months, excluding a 3-month blanking period.></0.001),>

Freedom from atrial arrhythmia recurrence at 12 months was 70% in the paroxysmal cohort and 62% in the persistent. Additionally, clinical success, freedom from recurrence of any symptomatic atrial arrhythmias, was 80% for paroxysmal and 81% for the persistent cohort.

About Patient Monitoring Strategies : Published PFA studies utilize different monitoring frequency and endpoints. For PULSED AF, patients underwent rigorous arrhythmia monitoring with assessments at three, six, and 12 months, and weekly symptomatic trans-telephonic monitoring. 96% (287) of patients completed the 12-month follow up. PFA study results cannot be directly compared; however, to show the impact of how monitoring differences affect outcome measurements, Medtronic analyzed its own data using the monitoring frequency and endpoints used in other PFA studies9 and found the PULSED AF outcomes to be higher when using those metrics.

The single-shot PulseSelect System delivers pulsed electric fields through an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that trigger AF. However, unlike traditional methods of ablation that heat (radiofrequency 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. Worldwide, the PulseSelect System is investigational and not approved for sale or distribution.

See-

"Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial"; Atul Verma, David E. Haines, Lucas V. Boersma, Nitesh Sood, Andrea Natale, Francis E. Marchlinski, Hugh Calkins, et al., on behalf of the PULSED AF Investigators. Originally published6 Mar 2023 https://doi.org/10.1161/CIRCULATIONAHA.123.063988Circulation. 2023;0.