RecruitingParoxysmal Atrial Fibrillation (PAF)Persistent Atrial Fibrillation
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: Boston Scientific Corporation
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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 surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)
- ✕ 3. Any prior atrial surgery
- ✕ 4. Current atrial myxoma
- ✕ 5. Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)
- ✕ 6. Current left atrial thrombus
- ✕ 2. Any of the following cardiovascular conditions:
Where it's recruiting
Source: ClinicalTrials.gov · NCT07575269 · last updated 2026-08-06