Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

Recruiting now · Not applicable

Conditions studied: Atrioventricular Block

In brief

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

Key facts

Study ID

NCT05774262

Run by

American Heart of Poland

People needed

300

Starts

2023-09-01

Expected to finish

2026-12-31

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Status post cardiac surgery
• Acute myocardial infarction and heart failure (not related to bradycardia)
• Status post percutaneous valvular intervention or ablation
• Acute infection or any other accompanying disease which is contraindication to percutaneous procedures and/or implantation of a pacemaker
• Pregnancy, nursing or planned pregnancy within 12 months
• Decompensated chronic diseases (endocrine disorders, electrolyte disorders, etc.)
• Advanced cardiomyopathies with indication for ICD implantation in primary or secondary prevention of sudden cardiac death (SCD)
• Advanced ventricular arrhythmias with indication for ICD implantation in primary or secondary prevention of SCD
• Persistent right or left bundle branch block
• Musculoskeletal diseases with separate indications for pacemaker implantation
• Contraindications to the procedures used in the study
• The presence of a mental illness or limitation of cognitive functions that prevent independent participation in the study, including the use of telemedicine services
• Any abnormality found that is considered by the Principal Investigator a contraindication to participate in the stidy due to data interpretation or safety issue

Where it is running

• American Heart of Poland — Dąbrowa Górnicza, Poland (enrolling)
• American Heart of Poland — Mielec, Poland (enrolling)

Full record on ClinicalTrials.gov

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