A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. ≥ 18 years of age, or older if required by local law 2. Have symptomatic drug-refractory1, persistent AF2, confirmed by both: * Documentation, such as physician note, of persistent continuous AF for \> 7 days and ≤ 365 days and the arrhythmia symptoms * Documentation, within 180 days of enrollment date of either: * 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 3. Willing and capable of providing informed consent 4. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center 5. Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions