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
Qualifiers
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
Treatments tested in this trial
- Cardioneuroablation
- Sham Control
Treatment groups
188 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov