RecruitingNot ApplicableNCT07575269

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation

Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study


Sponsor

Boston Scientific Corporation

Enrollment

571 participants

Start Date

Jul 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is: Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients? Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FARAFLEX Mapping and Pulsed Field Ablation (PFA) System for people with paroxysmal atrial fibrillation (paf) and persistent atrial fibrillation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFARAFLEX Mapping and Pulsed Field Ablation (PFA) System

Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.


Locations(6)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Mount Sinai Medical Center-Hospital

New York, New York, United States

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Christus Trinity Mother Frances Health System-Hospital

Tyler, Texas, United States

Mater Private Hospital-Hospital

Dublin, Dublin, Ireland

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NCT07575269


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