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NOT YET RECRUITING
NCT06952023
NA

PFA-based Bi-atrial Maze-like Catheter Ablation for PeAF

Sponsor: The First Affiliated Hospital of Dalian Medical University

View on ClinicalTrials.gov

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

PROCEDURE

Modified Maze ablation with PFA

Modified Maze ablation with PFA

PROCEDURE

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