Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)

Atrial fibrillation (AF) is associated with both electrical and structural remodeling of the left atrium. While successful catheter ablation has been shown to reverse some aspects of atrial remodeling, the impact of pulsed-field ablation (PFA) - a non-thermal ablation technology that selectively targets cardiomyocytes while sparing surrounding structures - on atrial remodeling in patients with persistent AF undergoing extensive substrate modification remains unclear. This is a prospective, single-center, single-arm observational study conducted at Taipei Veterans General Hospital. The study will enroll 30 patients with persistent atrial fibrillation who undergo pulmonary vein isolation (PVI) and extensive substrate modification using the FARAWAVE / FARADRIVE Catheter and FARASTAR System. The primary objective is to evaluate left atrial structural remodeling following PFA, including changes in LA size, atrial strain, extent of atrial fibrosis, and atrial hemodynamic function. The secondary objective is to assess AF-free survival between 3 and 12 months after the procedure, and its relationship to atrial remodeling. All participants will be followed for 12 months, with an interim analysis conducted once all subjects complete their 6-month follow-up.

NCT Number	NCT07675395
Lead Sponsor	Taipei Veterans General Hospital, Taiwan Collaborators: Boston Scientific Corporation
Conditions	Persistent Atrial Fibrillation, Atrial Fibrillation (AF), Atrial Remodeling, Pulsed Field Ablation
Enrollment	30 participants
Start Date	2026-07-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-02