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

Persistent Atrial Fibrillation Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05152966
Study type Interventional
Source Farapulse, Inc.
Contact
Status Completed
Phase N/A
Start date September 16, 2021
Completion date December 1, 2022
View Details
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