NCT05272852

The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation

PersAFOne III: Feasibility Study of the FARAPULSE Pulsed Field Ablation System Plus - PersAF in the Treatment of Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL

Detailed description

PersAFOne III study is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	FARAPULSE™ Pulsed Field Ablation System Plus	Ablation using FARAPULSE™ Pulsed Field Ablation System Plus

Timeline

• Start date: 2022-02-03
• Primary completion: 2024-02-09
• Completion: 2024-02-09
• First posted: 2022-03-10
• Last updated: 2025-01-08
• Results posted: 2025-01-08

Locations

2 sites across 1 country: Czechia

Regulatory

• FDA-regulated device study