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
Symptomatic first degree AVB (above 300 msec). Class IIaC
Symptomatic Mobitz type I second degree AVB. Class IIaC
Implanted pacemaker/ICD/CRT
Sinus node dysfunction with indication for pacemaker implantation
Planned ablation of the atrioventricular junction
Severe prolonged bradycardia in advanced AVB requiring intravenous drugs and temporary pacing
Parallel
Pacemaker implantation
Procedure/SurgeryElective pacemaker implantation (DDDR) for functional AVB according to the 2021 ESC Guidelines for Cardiac Pacing
Cardioneuroablation (CNA)
Procedure/SurgeryExperimental method; elective implantable loop recorder (ILR) and biatrial, binodal, atomically and electroanatomically guided CNA with extracardiac vagal nerve stimulation (ECVS) prior and after procedure monitoring (disappearance of ECVS-induced AVB with the goal of achieving post-procedure and maintaining a target heart rate \> 50 beats per minute). CNA procedure is performed with radio-frequency generators and irrigated catheters and with support of 3D-electroanatomic mapping system. CNA group will receive external ECG recorders. The major reason for external ECG recorders is to provide documentation of clinical AVB, as well as monitoring of patients before and after CNA (or PM implantation, if accepted). In case of severe AVB symptoms always the emergency system will be called.
To determine the efficacy of CNA in the treatment of AVB in comparison to PM therapy within 12 months of PM implantation/CNA procedure.
This is objective endpoint examining the onset of AVB episodes after PM/CNA. It will specify the number of pauses \> 3.0 s in the ECG external recorder for group B (occurrence of \> 1 pause or the need for earlier (0-12 months) PM implantation will be an indicator of the failure of the CNA procedure), assuming the presence of PM stimulation in group A at the level between 93-100% (equates to the continued duration of the AVB treated with PM).
Occurrence of MACE (major advers cardiac events)
MACE are defined as peri-procedural and long-term complications: death, stroke, myocardial infarction, pericardial effusion requiring drainage, AVB, venous thrombosis, infection, hemorrhage, hematoma, fistula, pseudoaneurysm, surgical intervention
Assessment of the effect of CNA and PM implantation on AVB symptoms based on based on VAS (Visual Analog Scale)
VAS (Visual Analog Scale) indicates the general health status with100 indicating the best health, 0 indicating the worst health status.
Assessment of the effect of CNA and PM implantation on health-related quality of life (QOL) based on questionaire EQ-5D-5L
EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1-5 ponts, that describes the patient's health state. The maximum score of 1 indicates the best health state, higher scores indicate more severe or frequent problems.
Assessment of the effect of CNA and PM implantation on health-related quality of life (QOL) based on questionaire SF-36
SF-36 questionnaire consists of 36 questions that are distributed across eight scales. Each scale is directly transformed into 0-100 scale. The lower the score the more disability, the higher the score the less disability.
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