Cardioneuroablation for Bradyarrhythmia

Not Applicable

Recruiting

• Conditions: Syncope; Sick Sinus Syndrome; Bradycardia
• Interventions: Procedure: Ganglionated plexi ablation; Diagnostic Test: Electrophysiological study

• Registration Number: NCT06288633
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Brief Summary

This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation

Detailed Description

Catheter ablation is a common treatment for cardiac arrhythmias. Some patients with AF ablation or AVNRT experience acceleration of sinus rhythm, the most likely cause of which is modification of autonomic tone caused by inadvertent damage to intramural autonomic ganglia and fibers. Intentional damage to these plexuses has become known as cardioneuroablation (CNA) and is currently used in patients with tachycardia-bradycardia syndrome, vegetatively caused sinus node dysfunction and atrioventricular conduction disorders, vasovagal syncopal conditions developing in a cardioinhibitory type.

It is suggested that in some patients CNA may become an alternative to permanent pacemaker for the treatment of symptomatic bradyarrhythmias.

This is a multicentre randomised clinical study evaluating the efficacy of cardioneuroablation for severe bradycardia due to sinus node dysfunction and/or atrioventricular nide dysfunction versus a sham procedure.

Study Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-25
• Status Verified: 2024-03
• Study First Posted: 2024-03-01
• Study Start: 2024-03-04
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardioneuroablation	Ganglionated plexi ablation	Radiofrequency catheter transmyocardial ablation of the ganglion plexuses (GP) of the atria - cardioneuroablation. The procedure is performed under local anesthesia using intracardiac catheters. Radiofrequency applications will be applied to the endocardial surface of the left and/or right atria in places of typical localization of the densest GPs network in order to destroy nerve fibers and ganglia: in patients with sinus bradycardia - in the left and right atria (5 places with the highest concentration of ganglia); in patients with impaired atrioventricular conduction - in the right atrium and in the left atrium (1 place in the right atrium - at the ostium of the coronary sinus; 2 places in the left atrium - opposite the ostium of the coronary sinus and opposite the Marshall ligament/vein).
Sham group	Electrophysiological study	In the control (sham) group, endocardial electrophysiological study will be performed, but patients will not know which procedure they performed (they are "blinded" in relation to the distribution group). The monitoring will be performed according to the same protocol as in the cardioneuroablation group. In case of recurrence of symptomatic bradycardia and/or (with) syncopal condition without traumatization of the patient in the control group, a transition to the cardioneuroablation group (cross-over) will be proposed. In case of disagreement, a pacemaker is implanted.

Primary Outcome Measures

Name	Time	Method
Implantation of a permanent cardiac pacemaker	12 months post procedure	Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered

Secondary Outcome Measures

Name	Time	Method
Complications of cardioneuroablation	30 days post procedure	Cardiac tamponade, pericardial effusion \>10 mm, esophageal damage, stroke or transient ischemic event, severe groin hematoma (hemoglobin level drop \>20%), atriovenous fistula in the groin
Presence of symptomatic or asymptomatic rhythm pauses >6 seconds	12 months post procedure	As detected by ECG monitoring
Implantation of a pacemaker by 24 months after randomization	24 months post procedure	Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime	12 months post procedure	As detected by ECG monitoring
Sinus tachycardia after cardioneuroablation	30 days post procedure	As detected by ECG monitoring, defined as daytime mean heart rate \>100 bpm
Transient or permanent atrioventricular block	12 months post procedure	As detected by ECG monitoring
Orthostatic hypotension and/or bradycardia during passive orthostasis test	12 months post procedure	Tilt-testing

Trial Locations

Locations (1)

Almazov National Medical Research Centre; 🇷🇺 Saint Petersburg, Russian Federation