About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of persistent atrial fibrillation
Left atrial anteroposterior (AP) diameter greater than 4 cm and less than 6 cm
Anti-arrhythmic medications (except amiodarone) discontinued for at least 5 half-lives before the procedure
No use of beta-blockers or diuretics before or after the ablation procedure
Disqualifiers
Paroxysmal atrial fibrillation
Previous left atrial surgery or catheter ablation procedure, including left atrial appendage closure
Atrial fibrillation due to reversible causes, such as thyroid disorders, acute alcohol intoxication, or other major surgeries within the 90 days preceding the procedure
Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass grafting within 90 days of the procedure
Trial design
Treatments tested in this trial
- Pulsed-Field Ablation with FARAWAVE Catheter System
Treatment groups
Sponsors and collaborators
Taipei Veterans General Hospital, Taiwan
Lead sponsor
Boston Scientific Corporation
Collaborator