Cardioneuroablation for Bradyarrhythmia

Launched by FEDERAL STATE BUDGETARY INSTITUTION, V. A. ALMAZOV FEDERAL NORTH-WEST MEDICAL RESEARCH CENTRE, OF THE MINISTRY OF HEALTH · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called cardioneuroablation for people who experience bradycardia, which is a slow heart rate that can cause symptoms like fainting or dizziness. The study aims to see if this treatment can help manage these symptoms without needing a permanent pacemaker. It is open to adults aged 18 to 65 who have specific types of bradycardia, especially if they have experienced fainting spells related to their heart condition. However, certain medical histories and conditions might exclude someone from participating.

Participants in the trial can expect to be randomly assigned to either receive the cardioneuroablation treatment or a sham procedure, which is a fake treatment that helps researchers compare results. The trial is currently recruiting, and it involves multiple centers, meaning it’s taking place in different locations. If you or someone you know is considering joining this study, it’s important to discuss eligibility with a healthcare provider to see if it might be a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Any of the following variants of bradyarrhythmia in patients aged 18-65 years:
• • (1.1.) Symptomatic sinus bradycardia or bradycardia due to atrioventricular blockade, including transient.
• • (1.2.) Severe asymptomatic sinus bradycardia with a rhythm frequency of \<30 beats/min.
• • (1.3.) Transient atrioventricular block of II-III degree or permanent block of II degree.
• • (1.4.) Repeated fainting or pre-fainting states with a proven association with bradycardia (without injury).
• • (1.5.) Rhythm pauses \>6 seconds.
• In combination with the following two criteria:
• 2. Positive reaction to physical activity and/or atropine test:
• • (2.1.) Increase in sinus rhythm frequency ≥25% or \>90 beats/min. (2.2.) The transition of atrioventricular blockade of the II-III degree to the 1st degree or complete normalization of atrioventricular conduction at the sinus rhythm.
• • 3. Sinus rhythm at the time of switching on
• Exclusion Criteria:
• • 1. Anamnesis of injury during syncopation due to bradycardia, except in the case when the patient refused to implant an electrocardiostimulator for his own reasons in writing;
• • 2. Constant intake of antiarrhythmic drugs (for PVC, AF, etc.);
• • 3. The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator;
• • 4. Drug-induced sinus bradycardia and/or atrioventricular block;
• • 5. Bradycardia due to electrolyte imbalance (e.g. hyperkalemia);
• • 6. Bradycardia due to hypothyroidism or other reversible conditions;
• • 7. No reaction to the administration of atropine (up to a maximum dose of 0.2 mg / kg);
• • 8. Proven association of bradyarrhythmia with episodes of apnea/hypopnea in obstructive sleep apnea syndrome;
• • 9. Clinically significant coronary artery disease;
• • 10. Postinfarction cardiosclerosis;
• • 11. Hemodynamically significant congenital heart defects, including operated ones;
• • 12. Stroke or transient ischemic attack \<3 months;
• • 13. Open heart surgery in the anamnesis;
• • 14. Catheter interventions on coronary arteries or for cardiac arrhythmias \<3 days;
• • 15. Conditions after percutaneous coronary angioplasty \<3 months;
• • 16. Anamnesis of stable ventricular tachycardia on the background of bradycardia;
• • 17. Pregnancy or breastfeeding period