NCT06181578

Ganglion Plexus Ablation in Persistent Atrial Fibrillation

Efficacy and Safety Study of Adjunctive Ganglionated Plexus Ablation in Patients With Persistent Atrial Fibrillation: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ning Zhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.

Detailed description

1. Study Design: The study employs a parallel-group design with a 1:1 randomization ratio. Eligible patients meeting the specified criteria will be randomly assigned to either the conventional ablation group (pulmonary vein isolation + linear ablation) or the intervention group receiving additional ganglionated plexus ablation. 2. Intervention: Control Group: Conventional ablation (pulmonary vein isolation + linear ablation) Intervention Group: Conventional ablation + ganglionated plexus ablation (left superior, left inferior, right anterior, and right inferior ganglionated plexi) 3. Randomization and Sequence Generation: To ensure randomness and comparability, a computer-generated random sequence will be utilized. Specific steps include: * Pre-matching the numbers 1-50 with 50 random numbers. * Allocating each random number equally to 2 groups, with the assigned numbers representing the order of patient enrollment. * Performing the above steps using R. 5\. Data Collection: Baseline data, including demographics, medical history, and laboratory parameters, will be collected at the start. Intraoperative electrophysiological and ablation-related parameters, as well as postoperative adverse events, will be documented. Follow-up data will include postoperative survival, quality of life (assessed using the Atrial Fibrillation Effect on Quality-of-Life questionnaire), dynamic electrocardiogram recordings, recurrence of atrial fibrillation or other arrhythmias, rehospitalization for arrhythmia, and medication usage. 6\. Endpoints: * Primary Endpoints: Recurrence of atrial tachyarrhythmias; Echocardiographic parameters; Procedure-related adverse events * Secondary Endpoints: Atrial fibrillation burden; Radiofrequency ablation time; Patient postoperative quality of life; Healthcare resource utilization The trial's initiation date will be documented, and all procedures will be conducted at the Cardiovascular Department of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. The study will adhere to ethical guidelines and regulations, and informed consent will be obtained from all participants.

Conditions

• Atrial Fibrillation, Persistent
• Ganglionated Plexi
• Catheter Ablation

Interventions

Type	Name	Description
PROCEDURE	ganglionated plexus ablation	This intervention involves the targeted ablation of ganglionated plexus sites, specifically focusing on the left superior ganglionated plexus (LSGP), left inferior ganglionated plexus (LIGP), right anterior ganglionated plexus (RAGP), and right inferior ganglionated plexus (RIGP).

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-12-26
• Last updated: 2023-12-26