Boston Scientific has announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the Farapulse pulsed field ablation (PFA) system and adjunctive use of the Farapoint PFA catheter in patients with persistent atrial fibrillation (AF). Key findings from the study were presented at the second annual PFA Live Case Summit—part of the 2025 Heart Rhythm Society (HRS) annual meeting (24–27 April, San Diego, USA)—and simultaneously published in Circulation.
The Farapulse PFA system is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal AF, and is a unique new alternative to standard-of-care thermal ablation treatment, according to Boston Scientific.
The second phase of the ADVANTAGE AF trial studied the Farawave PFA catheter for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA), and the Farapoint PFA catheter for cavotricuspid isthmus (CTI) ablation, to treat typical atrial flutter (AFL).
All patients in the trial were continuously monitored after their procedure with the LUX-Dx insertable cardiac monitor (ICM) system, which is designed to detect recurrence of cardiac arrhythmias and assess AF burden. Findings from the trial met all prespecified safety and effectiveness endpoints, including:
- A 73.4% rate of freedom from AF, AFL and atrial tachycardia (AT), exceeding the performance goal of ≥40%
- A safety event rate of 2.4% and no reports of pulmonary vein stenosis, atrio-oesophageal fistula or phrenic nerve palsy, meeting the performance goal of ≤12%
- An 81% rate of freedom from symptomatic documented AF recurrence, defined as arrhythmia, clinical intervention, or use of escalated or new Class I/III anti-arrhythmic drugs
- Some 71.6% of patients having virtually no atrial arrhythmia (AA) burden—data suggest lower AA burden can be associated with fewer clinical interventions and improvements in quality of life—and 52% of patients having no residual AA events after the blanking period
- Some 96.4% of patients treated with the Farapoint PFA catheter having no recurrence of AFL
“Continuous rhythm monitoring in phase two of the ADVANTAGE AF study allowed for a detailed picture of patients’ cardiac rhythm after ablation, including asymptomatic AF recurrence, which is not often captured in US Food and Drug Administration [FDA] clinical trial monitoring but is important for the ability to provide more individualised care to patients,” said study principal investigator Vivek Reddy (Mount Sinai Health System, New York, USA). “The data collected in this trial continue to support the Farapulse PFA system as a safe and effective therapy, now with evidence highlighting positive results for its use in treating patients who suffer from persistent AF.”
This prospective, single-arm trial included 255 patients enrolled at 29 US sites who were treated with the Farawave PFA catheter and, of those, 141 patients also received CTI ablation with the Farapoint PFA catheter for AFL.
The Farapoint PFA catheter is a navigation-enabled point catheter that uses a smaller ablation footprint to create focal and linear-shaped lesions and integrates with Boston Scientific’s Opal HDx mapping system to provide visualisation of catheter placement during procedures.
“These positive study results are an important step forward in the continued innovation of the proven Farapulse PFA system and our broader portfolio of products that treat AF,” said Brad Sutton, chief medical officer of AF solutions at Boston Scientific. “The performance of the devices in this trial—the Farapoint and Farawave PFA catheters as well as the LUX-Dx ICM system—is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF.”
Boston Scientific states in a press release that it anticipates US FDA approval to expand the instructions-for-use labelling for its Farapulse PFA system to include persistent AF—as well as European and US regulatory approvals for the Farapoint PFA catheter—in the second half of 2025.
