This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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).
Recurrence of Atrial Tachycardia and Time to Recurrence
The first occurrence of sustained atrial arrhythmias (excluding atrial premature beats) lasting ≥30 seconds recorded between 91 to 365 days post-catheter ablation, including atrial fibrillation and atrial flutter, etc.
Time frame: 91 to 365 days post-catheter ablation.
Left Atrial Dimensions
Measurement of left atrial size, a key indicator of atrial remodeling, assessed as a primary outcome to evaluate the impact of the intervention on atrial structure.
Time frame: 1 to 365 days post-catheter ablation.
Left Ventricular Ejection Fraction, LVEF
Assessment of left ventricular ejection fraction as a primary outcome measure, providing crucial insights into post-intervention cardiac function and guiding the evaluation of the treatment's efficacy on overall heart performance.
Time frame: 1 to 365 days post-catheter ablation.
Procedure-Related Adverse Events
Occurrence of adverse events related to the procedure during the perioperative or follow-up period, including but not limited to death, myocardial infarction, cardiac tamponade, and stroke.
Time frame: 1 to 365 days post-catheter ablation.
Atrial Fibrillation Burden
Quantification of the burden of atrial fibrillation episodes throughout the follow-up period.
Time frame: 91 to 365 days post-catheter ablation.
Radiofrequency Ablation Time
Total duration of radiofrequency ablation during the procedure.
Time frame: Recorded during the catheter ablation procedure.
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Patient's Postoperative Quality of Life
Assessment using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire, providing insights into the impact of the procedure on the patient's quality of life.
Time frame: 1 to 365 days post-catheter ablation.
Costs of treatment
Including expenses associated with medical procedures, hospital stay, and additional healthcare resources. The treatment costs will be expressed as a relative ratio, calculated by dividing the treatment cost per patient by the mean treatment cost of the control group.
Time frame: From patient admission to discharge, averaging a duration of 3 days.