FARAPULSE™

The ADVENT Pivotal Trial sub-analysis compared FARAPULSE to standard-of-care thermal ablation (RFA and CBA) for recurrent Atrial Arrhythmia (AA). Patients treated with FARAPULSE showed a significantly greater reduction in AA Burden than thermal ablation.

Key Findings:

• Significantly greater quality-of-life (QoL) improvements in patients with AA Burden <0.1% vs. ≥10%
• Significantly lower risk for redo ablation, cardioversion, and hospitalization with AA Burden <0.1% vs. ≥0.1%
• FARAPULSE patients were significantly more likely to have AA Burden <0.1% than RFA and CBA

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 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