TELE-monitoring for Standard Pacemaker Implantation or Delayed Pacemaker Implantation After Autonomic/Electrophysiologic Evaluation and Cardioneuroablation for managEment of Functional atrioventriculaR Block - Randomized Controlled Study
The TELE-SPACER study is a multicenter, noncommercial, physician-initiated, proof-of-concept, prospective, randomized, controlled, unblinded clinical trial and registry designed to compare two methods of treatment of patients with functional Atrio-Ventricular Block (AVB): the guidelines-recommended elective pacemaker (PM) therapy vs cardiovascular autonomic tests (CAT), electrophysiologic assessment (EPS) with referral to cardioneuroablation (CNA) and reevaluation of indications for PM therapy. The main questions TELE-SPACER aims to answer are: * Can the investigators successfully treat functional AVB without implantable device (PM)? * Can the investigators prove the feasibility and safety and demonstrate non-inferiority of CNA procedure in patients with functional AVB, avoiding long-term permanent pacing, its limitations, complications and costs ? The TELE-SPACER trial will validate the European Society of Cardiology (ESC) recommendations (level C of evidence: expert opinion) for elective PM implantation and will introduce CNA as effective treatment in the functional AVB patient population. Functional AVB - defined as a persistent or paroxysmal AVB with a positive results of atropine test
• Written informed consent to participate in the study
• Age 18-75
• Indication (at least one) of the European Society of Cardiology (ESC) for elective pacemaker implantation due to isolated (without sinus node dysfunction and bundle branch block) paroxysmal, persistent or reflex atrioventricular block:
‣ Symptomatic first degree AVB (above 300 msec). Class IIaC
⁃ Symptomatic Mobitz type I second degree AVB. Class IIaC
⁃ AVB 2:1, even asymptomatic, but not during sleep. Class IIaC
⁃ Mobitz II type advanced 2nd degree AVB or complete block (3rd degree AVB). Class IC
⁃ Advanced AVB during AF regardless of symptoms, but not during sleep. Class IC
⁃ Reflex syncope in patients over 40 years of age with documented pauses within the AVB mechanism, symptomatic (\>3 sec) or asymptomatic \>6 sec. Class IC
⁃ Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism in the course of sick sinus syndrome (CSS). Class IC
⁃ Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism during tilt test. Class IC