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RECRUITING

NCT05774262

Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

Sponsor: American Heart of Poland

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-09-01

Completion Date

2026-12-31

Last Updated

2024-03-18

Healthy Volunteers

Conditions

Atrioventricular Block

Interventions

PROCEDURE

Pacemaker implantation

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

PROCEDURE

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.

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

Locations (2)

American Heart of Poland

Dąbrowa Górnicza, Poland