Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial
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
• 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:
• 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.
• Sinus rhythm at the time of switching on