NCT06364215

Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Detailed description

This is an investigator-initiated, prospective, randomized, multi-center, Investigational Device Exemption (IDE) study. Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI) using pulsed field ablation (PFA) with the FARAWAVE PFA catheter. Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy. The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.

Conditions

• Atrial Fibrillation Paroxysmal

Interventions

Type	Name	Description
DEVICE	Farapulse PFA, Pulmonary Vein Isolation alone	Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
DEVICE	Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation	Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-11-16
• Completion: 2025-11-16
• First posted: 2024-04-15
• Last updated: 2025-11-19

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study