Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia

This study adopts a strategy combining basic research with clinical investigation to systematically explore the therapeutic value of cardioneuroablation in the treatment of vagally-mediated bradycardia. The study design fully considers the complexity of the scientific question and the feasibility of clinical translation. Through rigorous experimental design and standardized operational procedures, the reliability and reproducibility of the study results are ensured.

Study Overview

• Status: Recruiting
• Conditions: Autonomic Nervous System Diseases; Symptomatic Bradycardia
• Intervention / Treatment: Procedure: Cardioneuroablation; Procedure: Sham Control

Detailed Description

In recent years, cardiac ganglionated plexus (GP) ablation has emerged as a novel minimally invasive electrophysiological intervention. By targeting and ablating overactive GPs, this technique aims to suppress aberrant vagal signaling and alleviate symptoms of bradycardia. It offers distinct advantages, including a mechanism-targeted approach and the avoidance of permanent device implantation. Previous studies have demonstrated the feasibility and clinical potential of this technique in patients with vasovagal syncope, particularly the cardioinhibitory type. Therefore, developing such a "device-free" interventional therapy addresses a pressing clinical need and holds significant medical importance. Results from preliminary small-scale clinical studies suggest that GP ablation can significantly reduce syncope recurrence, improve quality of life, and increase resting heart rate. However, higher-level evidence regarding the efficacy and safety of cardiac GP ablation for the treatment of symptomatic bradycardia is still lacking. Consequently, this study combines basic and clinical research to address the unresolved questions regarding cardioneuroablation, aiming to fill this evidence gap and establish an evidence-based therapeutic strategy for patients with significant, vagally-mediated bradycardia.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu He, PhD.; Phone Number: +86 138-1072-0787; Email: theliu@139.com

Study Locations

• China
  • China
    • Beijing, China, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Principal Investigator: Ning Zhou, Prof.
      • Contact: Liu He, PhD.; Phone Number: +86 138-1072-0787; Email: theliu@139.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age range: 18 - 65 years old
2. Have symptoms related to bradycardia (syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate and decreased activity endurance, etc.)
3. Meet one of the following conditions: ①Dynamic electrocardiogram shows an average heart rate of less than 50 beats per minute or there is a heart arrest lasting more than 3 seconds during the day; ②Transient second or third degree atrioventricular conduction block without hemodynamic disorders during the day
4. The atropine test showed that the sinus heart rate increased by ≥ 25%, or the heart rate was ≥ 90 beats per minute, or the atrioventricular conduction block was significantly improved to be no more than first-degree atrioventricular conduction block.

Exclusion Criteria:

1. A history of severe trauma caused by bradycardia
2. Regular use of antiarrhythmic drugs within the past 3 months
3. Prior implantation of a cardiac pacemaker
4. Existing implantation of, or indication for implantation of, electronic devices with pacing function, such as cardiac contractility modulators (CCMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices
5. Bradycardia or atrioventricular block caused by medications or other reversible factors (e.g., hyperkalemia, hypothyroidism)
6. Bradycardia or atrioventricular block associated with obstructive sleep apnea syndrome (OSAS)
7. Coronary revascularization within the past 3 months, or unstable coronary heart disease despite standardized medical treatment or revascularization
8. Stroke or transient ischemic attack (TIA) within the past 3 months
9. A history of open-heart surgery
10. Severe congenital heart disease
11. Complicated with severe ventricular arrhythmia
12. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) ≤ 35%
13. Severe cardiomyopathy, such as hypertrophic obstructive cardiomyopathy (HOCM), dilated cardiomyopathy (DCM), or cardiac amyloidosis
14. Severe aortic or mitral valve stenosis
15. Pregnancy or lactation period
16. Expected survival time of less than 1 year
17. Refusal to sign the informed consent form
18. Other conditions deemed ineligible by the researchers

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardioneuroablation group; Participants randomized to this group will undergo cardioneuroablation targeting atrial ganglionated plexi for treatment of functional bradyarrhythmia.	Procedure: Cardioneuroablation; The procedure is performed under local anesthesia with conventional sedation using 1-3 mg of midazolam. The decision to administer additional sedation is assessed based on the patient's level of consciousness. The femoral vein is punctured, and a sheath is placed. Through this femoral venous sheath, catheters are advanced via the right atrium to position electrodes in the coronary sinus and the right ventricle. Under the guidance of intracardiac echocardiography and fluoroscopy (X-ray), a transseptal puncture is performed. The ablation catheter is then introduced into the left atrium through the transseptal sheath to sequentially perform catheter ablation of the left atrial and, selectively, the right atrial ganglionated plexi.
Placebo Comparator: Sham Control Group; Participants randomized to this group will undergo a sham procedure without transseptal puncture or catheter ablation.	Procedure: Sham Control; Throughout the procedure, the patient continuously wears over-ear headphones playing music and an eye mask. The surgery is performed under local anesthesia with conventional sedation using 1-3 mg of midazolam. The decision to administer additional sedation is assessed based on the patient's level of consciousness. Preoperative preparation, femoral vein puncture, placement of electrode catheters, and the electrophysiological study protocol are the same as in the intervention group; however, no transseptal puncture, ganglion mapping, or catheter ablation is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram	Average heart rate measured using 24-hour ambulatory electrocardiogram monitoring.	Baseline, 1, 3, 6 and 12 months after ablation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	Autonomic Nervous Function Testing	Baseline, 12 months after ablation.
PR Interval by 24-Hour Ambulatory Electrocardiogram	PR interval measured using 24-hour ambulatory electrocardiogram monitoring.	Baseline, 1, 3, 6, and 12 months after ablation.
Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)	The Short Form-36 Health Survey (SF-36) is a validated questionnaire measuring health-related quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.	Baseline, 12 months after ablation.

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Ning Zhou, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Efficacy; cardioneuroablation; Symptomatic Bradycardia
• Additional Relevant MeSH Terms: Nervous System Diseases; Autonomic Nervous System Diseases
• Other Study ID Numbers: AnzhenKS2026006

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