Cardioneuroablation for treating bradycardia

Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial

This study is testing a new procedure called cardioneuroablation to see if it can help people with slow heart rates feel better without needing a permanent pacemaker.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (Academic / other)
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT06288633 on ClinicalTrials.gov

What this trial studies

This multicenter trial evaluates the efficacy and safety of cardioneuroablation as a treatment for symptomatic bradycardia, comparing it to a sham procedure. The approach involves catheter ablation targeting autonomic ganglia to potentially improve heart rhythm without the need for a permanent pacemaker. Eligible participants include those aged 18-65 with specific types of bradyarrhythmias and a positive response to physical activity or atropine tests. The study aims to determine if this method can serve as a viable alternative for patients suffering from severe bradycardia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with symptomatic bradycardia or related conditions that respond positively to physical activity or atropine.

Not a fit: Patients with a history of injury during bradyarrhythmia episodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an alternative to permanent pacemaker implantation for patients with symptomatic bradycardia.

How similar studies have performed: While cardioneuroablation is a novel approach, similar studies have shown promise in treating related cardiac conditions.

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

Where this trial is running

Saint Petersburg

• Almazov National Medical Research Centre — Saint Petersburg, Russia (Recruiting)

Study contacts

• Principal investigator: Evgeny Mikhaylov, Prof. — Almazov National Medical Research Centre
• Study coordinator: Aleksandr Vakhrushev, PhD

Conditions Bradycardia; Syncope; Sick Sinus Syndrome; bradycardia; cardioneuroablation; sinus node dysfunction; atrioventricular node dysfunction