Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Anzhen Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cardioneuroablation
Procedure/SurgeryThe 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
Procedure/SurgeryThroughout 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.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Cardioneuroablation groupExperimental treatment 1 intervention
Group B: Sham Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Average Heart Rate by 24-Hour Ambulatory Electrocardiogram
Average heart rate measured using 24-hour ambulatory electrocardiogram monitoring.
Time frame
Baseline, 1, 3, 6 and 12 months after ablation.Secondary outcomes
1
Heart Rate Variability
Autonomic Nervous Function Testing
Time frame
Baseline, 12 months after ablation.2
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.
Time frame
Baseline, 12 months after ablation.3
PR Interval by 24-Hour Ambulatory Electrocardiogram
PR interval measured using 24-hour ambulatory electrocardiogram monitoring.
Time frame
Baseline, 1, 3, 6, and 12 months after ablation.Sponsors and contacts
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Source ClinicalTrials.gov