Actively Recruiting
Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
Led by Beijing Anzhen Hospital · Updated on 2026-03-13
188
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the potential of cardioneuroablation, a minimally invasive catheter ablation technique targeting cardiac ganglionated plexi, for treating significant vagally-mediated bradycardia. This condition involves abnormally slow heart rates caused by overactive vagal nerve signals. The study combines basic science and clinical investigation to address the current lack of high-level evidence on the safety and effectiveness of this therapy, aiming to establish a reliable, evidence-based treatment strategy. This approach avoids permanent device implantation and focuses on suppressing abnormal vagal activity that contributes to bradycardia symptoms like syncope and fatigue. The study randomly assigns participants to one of two groups: one receiving cardioneuroablation targeting atrial ganglionated plexi through a catheter procedure performed under local anesthesia with sedation, and the other undergoing a sham procedure without ablation or transseptal puncture. The ablation involves catheter insertion through the femoral vein, positioning in the heart guided by imaging, and sequentially ablating specific nerve clusters in the atria. The sham procedure mimics the preparation and catheter placement but does not include ablation, with participants wearing headphones and an eye mask to maintain blinding. Participants will be monitored with 24-hour ambulatory electrocardiograms at baseline and at 1, 3, 6, and 12 months post-procedure to measure average heart rate, PR interval, and heart rate variability. Quality of life will be assessed with a standardized health survey at baseline and 12 months. The study emphasizes rigorous design and standardized procedures to ensure reliable and reproducible results. Participant involvement includes multiple follow-up visits over a year to assess heart rhythm changes, symptoms, and overall wellbeing, supporting a comprehensive evaluation of the intervention's impact.
CONDITIONS
Brief Title
Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Experiencing symptoms related to bradycardia such as syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate, or decreased activity endurance
- Have an average heart rate less than 50 beats per minute or heart arrest lasting more than 3 seconds during the day on electrocardiogram, or transient second or third degree atrioventricular conduction block without hemodynamic disorders
- Atropine test showing sinus heart rate increase of 25% or more, or heart rate of at least 90 beats per minute, or significant improvement of atrioventricular conduction block to no more than first-degree block
You will not qualify if you...
- 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 electronic devices with pacing function such as CCMs, ICDs, or CRT devices
- Bradycardia or atrioventricular block caused by medications or other reversible factors like hyperkalemia or hypothyroidism
- Bradycardia associated with obstructive sleep apnea syndrome
- Coronary revascularization within the past 3 months, or unstable coronary heart disease
- Stroke or transient ischemic attack within the past 3 months
- History of open-heart surgery
- Severe congenital heart disease
- Severe ventricular arrhythmia
- Severe cardiac insufficiency with left ventricular ejection fraction 35% or less
- Severe cardiomyopathy such as hypertrophic obstructive cardiomyopathy, dilated cardiomyopathy, or cardiac amyloidosis
- Severe aortic or mitral valve stenosis
- Pregnancy or lactation
- Expected survival less than 1 year
- Refusal to sign informed consent
- Other conditions deemed ineligible by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up
Participants undergo either cardioneuroablation, a minimally invasive catheter ablation procedure targeting atrial ganglionated plexi, or a sham control procedure under local anesthesia with sedation.
1 procedure visit
Duration - 12 months
Participants are monitored with ambulatory electrocardiograms and quality of life assessments to evaluate heart rate and related outcomes after treatment.
Visits at 1, 3, 6, and 12 months post-procedure
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, China, 100029
Actively Recruiting
Research Team
L
Liu He, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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