NCT05774262 Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
| NCT ID | NCT05774262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American Heart of Poland |
| Condition | Atrioventricular Block |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-09-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Sebastian M Stec, MD, PhD
PRINCIPAL INVESTIGATOR
American Heart of Poland
Frequently Asked Questions
Who can join the NCT05774262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Atrioventricular Block. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05774262 currently recruiting?
Yes, NCT05774262 is actively recruiting participants. Contact the research team at smstec@wp.pl for enrollment information.
Where is the NCT05774262 trial being conducted?
This trial is being conducted at Dąbrowa Górnicza, Poland, Mielec, Poland.
Who is sponsoring the NCT05774262 clinical trial?
NCT05774262 is sponsored by American Heart of Poland. The principal investigator is Sebastian M Stec, MD, PhD at American Heart of Poland. The trial plans to enroll 300 participants.