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Studies

Interventional Active not recruiting

NCT05986526 on ClinicalTrials.gov

The PIFPAF-PFA Study

Official title: Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study

  • Sponsor: University Hospital of Bern
  • Enrollment: 206 (Actual)
  • Study start: 2023-11-13 (Actual)
  • Primary completion: 2026-02-13 (Actual)
  • Study completion: 2028-02-13 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Persistent Atrial Fibrillation

Intervention / Treatment

  • Procedure: Pulmonary vein isolation without posterior wall ablation
  • Procedure: Pulmonary vein isolation with posterior wall ablation

Primary Outcome Measures

  • Time to first recurrence of any atrial tachyarrhythmia day 91-365 (Day 91-365 post-ablation)
    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)

Countries

Switzerland

Locations and Investigators

  • Cantonal Hospital Baden, Baden, Switzerland
  • University Hospital Basel, Basel, Switzerland
  • Inselspital, University Hospital Bern, Bern, Switzerland
  • University Hospital Lausanne, Lausanne, Switzerland
  • Cantonal Hospital St. Gallen, Sankt Gallen, Switzerland
  • University Hospital Zürich, Zurich, Switzerland

Study Officials