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Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

Study acronym: TELE-SPACER
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 18, 2024 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05774262
Lead Sponsor American Heart of Poland
Conditions
(from sponsor)		 Atrioventricular Block
Related terms Atrioventricular Block
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov