Medtronic has announced findings from a secondary analysis of the PULSED AF study, demonstrating positive results for the Medtronic PulseSelect pulsed field ablation (PFA) system including atrial arrhythmia (AA) burden reduction, which correlated to improved quality of life and decreased healthcare utilisation.
In the study, 87% of paroxysmal (PAF) and 82% of persistent (PsAF) AF patients experienced less than 10% of AA burden. The results were presented in a late-breaking trial session at the Heart Rhythm Society’s 2023 annual meeting (19–21 May, New Orleans, USA) and published in Heart Rhythm.
PULSED AF is the first and only completed, global, and multicentre US Food and Drug Administration (FDA) investigational device exemption (IDE) clinical study for a PFA system and evaluated the safety and effectiveness of the PulseSelect system for AF ablation. Results of PULSED AF were first presented as late-breaking science at ACC.23/WCC in March, demonstrating the study exceeded its safety and efficacy performance goals.
“These are first of its kind results for PFA technology, moving us beyond the traditional binary efficacy endpoint to a more holistic picture of patients’ arrhythmia experience. Most novel is that this study shows us that treatment with the Medtronic PulseSelect PFA system results in low burden, which we know supports significant quality-of-life improvements and is something clinicians and patients consider when choosing a treatment option,” said Atul Verma (McGill University Health Centre, Montreal, Canada), principal investigator for the PULSED AF study.