Ganglion Plexus Ablation in Persistent Atrial Fibrillation

NCT06181578 | Unknown

• 1 other identifier: zn101516
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation, Persistent; Ganglionated Plexi; Catheter Ablation

Keywords

persistent atrial fibrillation; catheter ablation; ganglionated plexus; high-frequency stimulation; autonomic nervous system; treatment outcome; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Atrial Fibrillation Burden

  91 to 365 days post-catheter ablation.

• Radiofrequency Ablation Time

  Recorded during the catheter ablation procedure.

• Patient's Postoperative Quality of Life

  1 to 365 days post-catheter ablation.

• Costs of treatment

  From patient admission to discharge, averaging a duration of 3 days.

Study Arms (2)

GP Ablation Group

EXPERIMENTAL

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

Standard Ablation Group

NO INTERVENTION

Participants in this group will undergo standard ablation treatment, which includes pulmonary vein isolation (PVI) and linear ablation.

Interventions

ganglionated plexus ablation PROCEDURE

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).

GP Ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ning Zhou: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ning Zhou, Ph.D

CONTACT

+8613871249571; zhouning@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study employs a single-blind design, where the research staff is aware of the patient's group assignment, but the patients themselves are unaware of their group allocation. This approach is implemented to minimize potential subjective bias. The research staff will make efforts to maintain blinding during interactions with the patients to ensure objectivity in data collection and outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share