Pulsed Field Ablation System
|*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.|
ADVENT Pivotal Trial
- 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.