Comparing pacemaker implantation and cardioneuroablation for treating atrioventricular block

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

This study is testing whether a new treatment called cardioneuroablation is as safe and effective as traditional pacemaker implantation for people aged 18-75 with atrioventricular block.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: American Heart of Poland (other)
• Locations: 2 sites (Dąbrowa Górnicza and 1 other locations)
• Trial ID: NCT05774262 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with indications for elective pacemaker implantation due to functional atrioventricular block and positive atropine tests.

Not a fit: Patients with atrioventricular block not meeting the inclusion criteria or those with contraindications for either treatment method may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with functional atrioventricular block, reducing reliance on permanent pacemakers.

How similar studies have performed: While the approach of cardioneuroablation is novel, similar studies have shown promise in treating autonomic dysfunction, suggesting potential for success.

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

Where this trial is running

Dąbrowa Górnicza and 1 other locations

• 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

Conditions: Atrioventricular Block, AVB, Pacemaker implantation, Cardioneuroablation, Cardiovascular autonomic testing, Telemedicine