FARAPULSE™

The first and only randomized clinical trial that directly compares PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA), for the treatment of paroxysmal atrial fibrillation (PAF)).

Key Findings:

• The FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation
• Met the primary safety and efficacy non-inferiority endpoints
• Showed no instances of serious thermal complications

A retrospective observational study of the real-world commercial use of FARAPULSE PFA including data from 106 centers (91.4% of all commercial centers using FARAPULSE), 413 operators, and 17,642 patients.

Key Findings:

• Major adverse event rates were low (<1%)
• No reports of esophageal fistula, pulmonary vein stenosis or persistent phrenic nerve injury in the largest PFA registry to date

A retrospective survey of 24 centers with 77 operators and 1,568 AF ablation patients that assessed the real-world performance (use case, acute effectiveness, safety) of FARAPULSE in post-approval clinical use.

Key Findings:

• Freedom at 1-year from clinically documented recurrent arrhythmia was 81.6% in paroxysmal AF
• In a large cohort of unselected patients, PFA was efficacious for pulmonary vein isolation, and expressed a safety profile consistent with preferential tissue ablation

A multi-center registry studying the real-world adoption, workflow, acute and long-term outcomes after PFA in an all-comer atrial fibrillation (AF) patient population in high-volume European centers.

Key Findings:

• Demonstrated rapid adoption of the technology by new operators and prior RF and cryo users
• Operator experience and previous primary ablation modality did not have an effect on one-year recurrence rates