Clinical Trial

The PIFPAF-PFA Study

Study acronym: PIFPAF-PFA
Active, Not Recruiting
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Summary
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-28
Trial Details
NCT Number NCT05986526
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions Persistent Atrial Fibrillation
Enrollment 206 participants
Start Date 2023-11-13
Primary Completion 2026-02-13 (estimated)
Study Completion 2028-02-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-27