A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

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

Treatment groups

699 Participants
are divided into 2 treatment groups

Sponsors and collaborators