Clinical Research Directory
Browse clinical research sites, groups, and studies.
Atrial Remodeling After PFA Substrate Modification for Persistent AF (PeAF)
Sponsor: Taipei Veterans General Hospital, Taiwan
Summary
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.
Official title: Pulsed-Field Ablation for Persistent Atrial Fibrillation: Impact of Atrial Remodeling After Substrate Modification
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-07-01
Completion Date
2028-12-31
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
Pulsed-Field Ablation with FARAWAVE Catheter System
Pulsed-field ablation is performed using the FARAWAVE / FARADRIVE Catheter and FARASTAR System (Boston Scientific) under deep sedation or general anesthesia. PFA is delivered to achieve pulmonary vein isolation and posterior wall isolation, with additional substrate modification at the operator's discretion. Invasive hemodynamic assessment is performed pre- and post-PFA during the index procedure and repeated at approximately 3 months.
Locations (1)
Taipei Veterans General Hospital
Taipei, Taiwan