Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
Treatment groups
571 Participants
are divided into 1 treatment groupLocations
1Texas Cardiac Arrhythmia Research78705, AustinTexas, United States
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov