Recruiting
Not applicable
Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
Condition(s) studied
Symptomatic BradycardiaAutonomic Nervous System Diseases
Investigational drug(s) / intervention(s)
CardioneuroablationSham Control
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.
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.
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram — Baseline, 1, 3, 6 and 12 months after ablation.
Average heart rate measured using 24-hour ambulatory electrocardiogram monitoring.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Beijing Anzhen Hospital, Capital Medical University |
Beijing |
China |
Recruiting |
More Beijing Anzhen Hospital trials in China
Other trials for the same condition