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PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF
Sponsor: The First Affiliated Hospital of Dalian Medical University
Summary
In radiofrequency (RF) ablation of persistent atrial fibrillation (PeAF), the additional linear ablation beyond pulmonary vein isolation (PVI) does not yield an reduce atrial arrhythmias recurrences.The goal of this clinical trial is to evaluate the efficiency of pulsed filed (PF) energy-based bi-atrial modified Maze ablation vs PF energy-based PVI of PeAF. The main questions it aims to answer are: Does PF energy effectively perform linear ablation in the left atrium? Does PFA-based bi-atrial modified Maze ablation significantly improve the success rate of PeAF ablation compared with PFA-based PVI? Patients with PeAF who meet the criteria and undergo catheter ablation will be randomly assigned to the study group (PF-based bi-atrial modified Maze ablation group) and control group (PF-based PVI only) in a 1:1 ratio. All patients will received a 7-d Holter at 3-,6-,9-,12-month after the ablation. The primary endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month after the procedure without taking I/III AADs.
Official title: Pulsed Field-Based Bi-atrial Maze-like Catheter Ablation Versus Pulmonary Vein Isolation in Persistent Atrial Fibrillation: A Multi-center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2025-06
Completion Date
2027-10
Last Updated
2025-04-30
Healthy Volunteers
No
Interventions
Modified Maze ablation with PFA
Modified Maze ablation with PFA
PVI only with PFA
PVI only with PFA
Locations (3)
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Affiliated Hospital Of Medical School Of Ningbo University
Ningbo, Zhejiang, China