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A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation — FARA-Free  

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation

Clinical Trial Summary

The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).

Clinical Trial Description

This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 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 NCT04474054
Study type Interventional
Source Farapulse, Inc.
Contact
Status Completed
Phase N/A
Start date July 7, 2020
Completion date December 21, 2021
View Details
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