FARAPULSE™
Pulsed Field Ablation System
| *Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. |
ADVENT Trial Study
Purpose
Procedure
Feasibility data
- 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.
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ADVENT Trial Study
Purpose: This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.
ADVANTAGE AF Trial Study
Purpose: The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).
Pulsed Field Ablation Therapy
Discover how PFA is shaping the future of cardiac ablation for paroxysmal AF.
Pre-Clinical Data
See the pre-clinical data evaluating the use of the FARAPULSE Pulsed Field Ablation System
ADVENT Trial Feasibility Data
- 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.
ADVANTAGE AF Trial Feasibility Study
- In PersAFOne, persistent AF patients underwent PVI and LA posterior wall ablation (LAPW) using a basket and flower PFA catheter.
- In 25 patients, acute PVI was achieved in 100% of PVs, and in 24 patients, 100% of LAPWs with PFA alone with the basket and flower PFA catheter.
- PV remapping, performed in 22 patients at an average of 82 days, demonstrated durable PVI in 96% of PVs (86% of patients), and 100% of LAPWs (21 of 21)
- The 1-year Kaplan-Meier estimate for freedom from any atrial arrhythmia was 92.5 + 5.4%.
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