NCT05152966

Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)

PersAFOne II(Pronounced Per-'Se-fa-nē 2); Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (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 Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL

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, 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	Ablation	Ablation using the FARAPULSE™ Cardiac Ablation System Plus

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2021-12-10
• Last updated: 2024-02-28
• Results posted: 2024-01-31

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study