Atrial Fibrillation Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• At least 18 years old (or older if required by local law)

• Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).

• Willing and capable of providing written informed consent

• Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Locations
United States
Texas
Texas Cardiac Arrhythmia Research
RECRUITING
Austin
Contact Information
Primary
Madalyn MacKinnon
Madalyn.MacKinnon@bsci.com
860-992-2724
Backup
Sara Veraghtert
Sara.Veraghtert@bsci.com
Time Frame
Start Date: 2026-06-12
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 571
Treatments
Experimental: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
Participants undergo a catheter procedure using the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to treat atrial fibrillation. The catheter is used to map the heart's electrical signals and deliver pulsed field ablation therapy.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov