NCT04170621

Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation

PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation

Detailed description

This 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, 75 ± 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	Ablation	Ablation using the FARAPULSE Endocardial Multi Ablation System

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-07-14
• Completion: 2021-07-14
• First posted: 2019-11-20
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

2 sites across 2 countries: Croatia, Czechia

Regulatory

• FDA-regulated device study