Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Symptomatic Bradycardia, Autonomic Nervous System Diseases
In brief
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.
Key facts
- Study ID
- NCT07468383
- Run by
- Beijing Anzhen Hospital
- People needed
- 188
- Starts
- 2025-08-01
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age range: 18 - 65 years old
- Have symptoms related to bradycardia (syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate and decreased activity endurance, etc.)
- 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
- 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.
You may not qualify if…
- A history of severe trauma caused by bradycardia
- Regular use of antiarrhythmic drugs within the past 3 months
- Prior implantation of a cardiac pacemaker
- 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
- Bradycardia or atrioventricular block caused by medications or other reversible factors (e.g., hyperkalemia, hypothyroidism)
- Bradycardia or atrioventricular block associated with obstructive sleep apnea syndrome (OSAS)
- Coronary revascularization within the past 3 months, or unstable coronary heart disease despite standardized medical treatment or revascularization
- Stroke or transient ischemic attack (TIA) within the past 3 months
- A history of open-heart surgery
- Severe congenital heart disease
- Complicated with severe ventricular arrhythmia
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) ≤ 35%
- Severe cardiomyopathy, such as hypertrophic obstructive cardiomyopathy (HOCM), dilated cardiomyopathy (DCM), or cardiac amyloidosis
- Severe aortic or mitral valve stenosis
- Pregnancy or lactation period
- Expected survival time of less than 1 year
- Refusal to sign the informed consent form
- Other conditions deemed ineligible by the researchers
Where it is running
- Beijing Anzhen Hospital, Capital Medical University — Beijing, China, China (enrolling)
Full record on ClinicalTrials.gov
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