Comparing pacemaker implantation and cardioneuroablation for treating atrioventricular block

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TELE-SPACER trial is a multicenter, randomized clinical trial designed to compare two treatment methods for functional atrioventricular block (AVB): traditional pacemaker implantation and a novel approach involving cardioneuroablation. Participants aged 18-75 with indications for pacemaker therapy will be randomized into two groups, one receiving pacemaker therapy and the other undergoing cardiovascular autonomic testing followed by cardioneuroablation. The study aims to assess the feasibility, safety, and non-inferiority of the cardioneuroablation procedure compared to standard pacemaker therapy, potentially avoiding the complications and costs associated with long-term pacing. The trial will also include a registry for participants opting out of randomization, allowing for tailored interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• American Heart of Poland
  Dąbrowa Górnicza, Poland Recruiting
• American Heart of Poland
  Mielec, Poland Recruiting

Study contacts

• Principal investigator: Sebastian M Stec, MD, PhD — American Heart of Poland
• Study coordinator: Sebastian M Stec, MD, PhD
• Email: smstec@wp.pl
• Phone: +48 600-298-022

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two pacemaker pacing methods for AV block

  This trial tests whether conduction system (left bundle branch area) pacing or standard right ventricular pacing works better for people with atrioventricular block who need a permanent pacemaker.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.