Table 1.

Inclusion and exclusion criteria in the TELE-SPACER trial and registry

Inclusion criteria

Written informed consent to participate in the study Age 18–75 years At least one indication of the European Society of Cardiology (ESC) for elective pacemaker implantation due to isolated (without SND and BBB) paroxysmal, persistent or reflex AVB: symptomatic first-degree AVB (above 300 msec). Class IIaC symptomatic second-degree AVB Mobitz type I. Class IIaC AVB 2:1, even asymptomatic, but not during sleep. Class IIaC advanced second-degree AVB Mobitz II type or complete block (third-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 (> 3 sec) with AVB mechanism, symptomatic >3 sec, or asymptomatic > 6 sec. Class IC reflex syncope in patients over 40 years of age with documented pauses with AVB mechanism in the course of SND. Class IC reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism during tilt test. Class IC

Exclusion criteria

SND with indication for PM implantation Severe, prolonged bradycardia in advanced AVB requiring temporary cardiac pacing Persistent RBBB or LBBB Advanced ventricular arrhythmia with indication for ICD implantation in primary or secondary prevention of SCD Recent catheter ablation of cardiac arrhythmias < 3 months Planned ablation of the AV junction Implanted PM/ICD/CRT Uncontrolled hypertension ESC 3 (BP ≥ 180/110 mmHg) Diabetes mellitus type 1 or 2 CKD — moderate to severe (eGFR < 60 mL/min/1.73 m2) Familial hypercholesterolemia (cholesterol > 8 mmol/L (> 310 mg/dL) High 10-year cardiovascular risk on SCORE2 for patients 40–69 years of age and on SCORE2-OP for patients 70–89 years of age Documented ASCV: clinically: CCS, myocardial infarction/ACS, coronary revascularization and other arterial revascularization procedures, stroke/TIA, aortic aneurysm, and PAD by imaging: the presence of atherosclerotic plaque in coronary angiography or ultrasound of the carotid arteries or in CTA (does not include an increase in the thickness of the intima-media complex in the carotid artery) Heart failure, including HFpEF Cardiomyopathies with indication for ICD implantation for primary or secondary prevention of SCD Previous cardiac surgery or percutaneous valve intervention Decompensated chronic diseases (endocrine, metabolic, electrolyte disorders, etc.) Musculoskeletal disorders with indication for PM implantation Acute infection or any other concomitant disease that is considered a contraindication for percutaneous procedures and/or PM implantation Pregnancy, breastfeeding, or planned pregnancy within 12 months The presence of a mental illness or limitation of cognitive functions that prevent independent participation in the study, including the use of telemedicine services Contraindications to the procedures used in the study Any identified abnormality that is considered by the investigator a contraindication to participation in the study due to data interpretation or safety issues