Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atria
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
| Condition(s) | Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Boston Scientific Corporation |
| Locations | Austin, Texas, United States |
| Start date | 2026-06-12 |
| NCT ID | NCT07575269 |
| Official listing | https://clinicaltrials.gov/study/NCT07575269 |