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.
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
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
Single group
Pulsed-Field Ablation with FARAWAVE Catheter System
DevicePulsed-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.
Change in Left Atrial Anteroposterior Diameter
Change from baseline in left atrial anteroposterior (AP) diameter measured by transthoracic echocardiography.
Change in Left Atrial Volume Index
Change from baseline in left atrial volume index measured by transthoracic echocardiography.
Change in Left Atrial Reservoir Strain
Change from baseline in left atrial reservoir strain assessed by transthoracic echocardiography with speckle-tracking analysis.
Change in Left Atrial Conduit Strain
Change from baseline in left atrial conduit strain assessed by transthoracic echocardiography with speckle-tracking analysis.
Atrial Fibrillation-Free Survival
Proportion of subjects free from any documented atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting ≥30 seconds following a 90-day blanking period after the index pulsed-field ablation procedure. Recurrence is assessed by 12-lead ECG and 14-day Holter monitoring performed between 3 and 12 months post-procedure.
Correlation Between Atrial Remodeling and Ablation Outcome
Correlation between post-procedural atrial structural remodeling parameters (left atrial size, atrial strain, extent of atrial fibrosis on delayed-enhancement cardiac MRI, and invasively measured atrial hemodynamic function) and atrial fibrillation-free survival following pulsed-field ablation. Each parameter's association with recurrence is expressed as a correlation coefficient. This analysis aims to identify imaging- and hemodynamic-based predictors of ablation success and to characterize the relationship between reverse atrial remodeling and clinical outcome.
Click on the lead sponsor to view all of their trials.
Taipei Veterans General Hospital, Taiwan
Lead sponsor
Boston Scientific Corporation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
