Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

NCT05774262 · tracked via the Priya Life Science Poland tracker

Sponsor

American Heart of Poland

Phase

Not applicable

Started

2023-09-01

Last updated

2024-03-18

Condition(s) studied

Atrioventricular Block

Investigational drug(s) / intervention(s)

Pacemaker implantationCardioneuroablation (CNA)

Pacemaker implantation: Elective pacemaker implantation (DDDR) for functional AVB according to the 2021 ESC Guidelines for Cardiac Pacing

Cardioneuroablation (CNA): Experimental 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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Written informed consent to participate in the study 2. Age 18-75 3. 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: 1. Symptomatic first degree AVB (above 300 msec). Class IIaC 2. Symptomatic Mobitz type I second degree AVB. Class IIaC 3. AVB 2:1, even asymptomatic, but not during sleep. Class IIaC 4. Mobitz II type advanced 2nd degree AVB or complete block (3rd degree AVB). Class IC 5. Advanced AVB during AF regardless of symptoms, but not during sleep. Class IC 6. 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 7. 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 8. Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism during tilt test. Class IC Exclusion Criteria: 1. Implanted pacemaker/ICD/CRT 2. Sinus node dysfunction with indication for pacemaker implantation 3. Planned ablation of the atrioventricular junction 4. Severe prolonged bradycardia in advanced AVB requiring intravenous drugs and temporary pacing 5. Status post cardiac surgery 6. Acute myocardial infarction and heart failure (not related to bradycardia) 7. Status post percutaneous valvular intervention or ablation 8. Acute infection or any other accompanying disease which is contraindication to percutaneous procedures and/or implantation of a pacemaker 9. Pregnancy, nursing or planned pregnancy within 12 months 10. Decompensated chronic diseases (endocrine disorders, electrolyte disorders, etc.) 11. Advanced cardiomyopathies with indication for ICD implantation in primary or secondary prevention of sudden cardiac death (SCD) 12. Advanced ventricular arrhythmias with indication for ICD implantation in primary or secondary prevention of SCD 13. Persistent right or left bundle branch block 14. Musculoskeletal diseases with separate indications for pacemaker implantation 15. Contraindications to the procedures used in the study 16. The presence of a mental illness or limitation of cognitive functions that prevent independent participation in the study, including the use of telemedicine services 17. Any abnormality found that is considered by the Principal Investigator a contraindication to participate in the stidy due to data interpretation or safety issue

Primary outcome measure(s)

To determine the efficacy of CNA in the treatment of AVB in comparison to PM therapy within 12 months of PM implantation/CNA procedure. — 12 months
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).

Trial sites (2)

Facility	City	Region	Status
American Heart of Poland	Dąbrowa Górnicza	Poland	Recruiting
American Heart of Poland	Mielec	Poland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05774262 on ClinicalTrials.gov ↗ ← All trials in Poland