Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation - A Global Prospective Single Arm Study
Boston Scientific Corporation
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years old (or older if required by local law) 2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF). 3. Willing and capable of providing written informed consent 4. Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site Exclusion Criteria: 1. Any of the following atrial conditions: 1. Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL 2. Any prior atrial endocardial, epicardial, or surg…
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.
Location
- Texas Cardiac Arrhythmia ResearchAustin, Texas