Cardiac ganglion catheter ablation to treat significant bradycardia

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

This trial will try catheter-based cardioneuroablation to see if ablating overactive cardiac ganglia reduces symptoms in adults with vagally-mediated symptomatic bradycardia compared with a sham procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, China)
• Trial ID: NCT07468383 on ClinicalTrials.gov

What this trial studies

This combined basic and clinical program uses standardized catheter ablation targeting cardiac ganglionated plexi to suppress excessive vagal signaling that contributes to symptomatic bradycardia. Participants undergo the ablation procedure or a sham control under a controlled protocol, with predefined safety and efficacy endpoints including heart rate changes and symptom recurrence. Parallel mechanistic basic-research work is integrated to improve understanding of how ganglion ablation alters autonomic control of the heart. The study emphasizes reproducible procedures and rigorous follow-up to establish both clinical effect and safety.

Who should consider this trial

Good fit: Adults 18–65 with symptomatic bradycardia meeting ECG or atropine criteria for vagally-mediated slowing, without prior pacemaker implantation and able to undergo catheter procedures, are the intended participants.

Not a fit: Patients with prior pacemaker implantation, recent regular antiarrhythmic use, non-vagal structural conduction disease, or those who have had severe trauma from bradycardia are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, cardioneuroablation could reduce syncope and other bradycardia symptoms and increase resting heart rate without requiring a permanent pacemaker.

How similar studies have performed: Small clinical series and trials in vasovagal syncope, particularly the cardioinhibitory type, have reported feasibility and reductions in syncope after ganglion ablation, but high-quality randomized evidence for symptomatic bradycardia remains limited.

Eligibility criteria

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

Where this trial is running

Beijing, China

• Beijing Anzhen Hospital, Capital Medical University — Beijing, China, China (Recruiting)

Study contacts

• Principal investigator: Ning Zhou — Beijing Anzhen Hospital
• Study coordinator: Liu He, PhD.

Conditions Symptomatic Bradycardia; Autonomic Nervous System Diseases; cardioneuroablation; Efficacy; Safety