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Pulsed Field Ablation System

*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

ADVENT Pivotal Trial

Trial Overview

The ADVENT Pivotal Trial will be the first randomized clinical trial to directly compare FARAPULSE™ effectiveness to radiofrequency ablation (RFA) or cryoballoon ablation (CBA).
A Randomized Controlled Trial of Pulsed Field Ablation versus Standard-of-Care Ablation for Paroxysmal Atrial Fibrillation: The ADVENT Trial Rationale and Design


Farapulse workflow animation

Feasibility data

Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II
  • In 3 multicenter studies (IMPULSE, PEFCAT and PEFCAT II), PAF patients underwent PVI using a basket and flower PFA catheter. 
  • Invasive remapping was performed at 2 to 3 months, and reconnected PVs were reisolated with PFA or radiofrequency ablation. After a 90-day blanking period, arrhythmia recurrence was assessed over 1-year follow-up. 
  • In 121 patients, acute PVI was achieved in 100% of PVs with PFA alone. 
  • PV remapping, performed in 110 patients at 93.0 ± 30.1 days, demonstrated durable PVI in 84.8% of PVs (64.5% of patients), and 96.0% of PVs (84.1% of patients) treated with the optimized biphasic energy PFA waveform. 
  • The 1-year Kaplan-Meier estimates for freedom from any atrial arrhythmia for the entire cohort and for the optimized biphasic energy PFA waveform cohort were 78.5 + 3.8% and 84.5 + 5.4%, respectively.
Farapulse clinical compendium