About this trial
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).
Eligibility criteria
Qualifiers
≥ 18 years of age, or older if required by local law
Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days and the arrhythmia symptoms
A 24-hour continuous ECG recording confirming continuous AF or
Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
Disqualifiers
Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume >100 ml (physician note or imaging)
Any prior left atrial ablation
Any prior atrial surgery
Current atrial myxoma
Trial design
Treatments tested in this trial
- FARAPOINT Pulsed Field Ablation System
- OptiMap System (non-ablative)
- FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System