Condition: Atrioventricular Block · Sponsor: American Heart of Poland
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
This description comes directly from the study's public registry record.
Sebastian M Stec, MD, PhD · +48 600-298-022 · smstec@wp.pl
Edyta Stodolkiewicz-Nowarska, MD PhD · +48 785-885-425 · edytastod@gmail.com
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| American Heart of Poland | Dąbrowa Górnicza, Poland | Recruiting |
| American Heart of Poland | Mielec, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05774262