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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Veterans General Hospital, Taiwan

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Taipei Veterans General Hospital, Taiwan

Lead sponsor

Boston Scientific Corporation

Collaborator