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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation, Persistent; Catheter Ablation; Ganglionated Plexi
• Intervention / Treatment: Procedure: ganglionated plexus ablation

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Zhou, Ph.D; Phone Number: +8613871249571; Email: zhouning@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 80 years, regardless of gender.
• Patients confirmed by electrocardiogram or clinically diagnosed with persistent atrial fibrillation.
• Individuals scheduled to undergo atrial fibrillation catheter ablation.
• Willing to participate in the study and voluntarily sign the informed consent form.

Exclusion Criteria:

• Patients with a history of prior atrial fibrillation ablation surgery.
• Left ventricular ejection fraction (LVEF) less than 35%.
• Left atrial anterior-posterior diameter greater than 50mm on echocardiography.
• Presence of contraindications for atrial fibrillation ablation, such as the presence of clear thrombus in the left atrium detected preoperatively.
• Patients with second-degree (Type II) or third-degree atrioventricular block.
• Individuals with significant congenital heart defects (such as atrial septal defects or severe pulmonary vein stenosis, excluding unclosed foramen ovale).
• Patients with implanted artificial valves.
• Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
• Untreated or uncontrolled hyperthyroidism or hypothyroidism.
• Patients with active systemic infections.
• Individuals with a significant bleeding tendency or those undergoing active blood dialysis due to renal failure.
• Patients who have experienced myocardial infarction within the last 3 months or undergone any cardiac intervention/open-heart surgery.
• Presence of clear contraindications for interventional procedures, as determined by the investigator.
• Pregnant or lactating women, or those planning pregnancy during the study period.
• Participation in other drug or medical device clinical trials within the last 3 months.
• Patients deemed unsuitable for participation in this clinical trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GP Ablation Group; Participants in this group will undergo a combined intervention, including standard ablation (pulmonary vein isolation and linear ablation) and additional ablation targeting the autonomic ganglionated plexus (GP).	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).
No Intervention: Standard Ablation Group; Participants in this group will undergo standard ablation treatment, which includes pulmonary vein isolation (PVI) and linear ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1 to 365 days post-catheter ablation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation Burden	Quantification of the burden of atrial fibrillation episodes throughout the follow-up period.	91 to 365 days post-catheter ablation.
Radiofrequency Ablation Time	Total duration of radiofrequency ablation during the procedure.	Recorded during the catheter ablation procedure.
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.	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.	From patient admission to discharge, averaging a duration of 3 days.

Collaborators and Investigators

• Sponsor: Ning Zhou

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; autonomic nervous system; treatment outcome; catheter ablation; persistent atrial fibrillation; high-frequency stimulation; ganglionated plexus
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: zn101516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No