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

Recruiting now · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT07575269

Run by

Boston Scientific Corporation

People needed

571

Starts

2026-07-07

Expected to finish

2030-01-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any of the following atrial conditions:
• Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL
• Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
• Any prior atrial surgery
• Current atrial myxoma
• Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
• Current left atrial thrombus
• Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia or ventricular fibrillation
• Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)
• Presence of any of the following cardiac devices or implants:
• Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device
• Current implantable loop recorder other than LUX-Dx
• Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))
• Left atrial appendage closure or occlusion device
• Clinically significant valvular disease, including:
• Any cardiac valve prosthesis, ring, repair, or clip
• Moderate to severe mitral stenosis
• Moderate to severe aortic stenosis
• Severe mitral regurgitation
• Severe tricuspid regurgitation
• Hypertrophic or amyloid cardiomyopathy
• Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access
• Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)
• Severe right ventricular dysfunction per investigator assessment

Where it is running

• Arrhythmia Research Group — Jonesboro, Arkansas, United States (enrolling)
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (enrolling)
• Mount Sinai Medical Center-Hospital — New York, New York, United States (enrolling)
• Texas Cardiac Arrhythmia Research — Austin, Texas, United States (enrolling)
• Christus Trinity Mother Frances Health System-Hospital — Tyler, Texas, United States (enrolling)
• Mater Private Hospital-Hospital — Dublin, Dublin, Ireland (enrolling)

Full record on ClinicalTrials.gov

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