Cardioneuroablation for treating bradycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: advakhrushev@gmail.com
• Phone: +78127023749

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias

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• Comparing cardioneuroablation and permanent pacing for treating bradycardia symptoms.

  This study is testing if a new treatment called cardioneuroablation can help people with slow heart rates feel better and possibly stop using their pacemakers.

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• Registry for implantable cardiac devices

  This study is tracking how well pacemakers and defibrillators work for people with heart rhythm problems to see if they can improve patient care and outcomes.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf · NCT03360227

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.