NCT05774262 (TELE-SPACER) is a NA clinical trial of Pacemaker implantation in Atrioventricular Block, sponsored by American Heart of Poland.

Who is sponsoring NCT05774262?

NCT05774262 is sponsored by American Heart of Poland.

What drugs are being tested in NCT05774262?

Interventions in NCT05774262: Pacemaker implantation, Cardioneuroablation (CNA).

What condition does NCT05774262 study?

NCT05774262 studies Atrioventricular Block.

Is NCT05774262 still recruiting?

NCT05774262 is currently recruiting now. Last updated 18 March 2024.

Last reviewed 2024-03-18 · How we verify

NCT05774262: TELE-SPACER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block

Recruiting now NA Last updated 18 March 2024

What this trial tests

NA trial testing Pacemaker implantation in Atrioventricular Block in 300 participants. Currently enrolling.

Timeline

1 September 2023

Primary endpoint
31 August 2026

31 December 2026

Quick facts

Lead sponsor	American Heart of Poland
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	1 September 2023
Primary completion	31 August 2026
Estimated completion	31 December 2026
Sites	2 locations across Poland

Drugs / interventions tested

Pacemaker implantation
Cardioneuroablation (CNA)

Conditions studied

Atrioventricular Block — all drugs for Atrioventricular Block →

Sponsor

American Heart of Poland

Who can join

Adults 18 to 75, any sex, with Atrioventricular Block. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS) and the Latin American Heart R
Aksu T, Brignole M, Calo L, Debruyne P, et al · · 2024 · cited 45× · PMID 39082698 · DOI 10.1093/europace/euae206
TELE-SPACER - a randomized clinical trial protocol: Cardioneuroablation versus pacemaker implantation in the treatment of vagally-mediated atrio-ventricular block.
Stodółkiewicz-Nowarska E, Stec S, Wileczek A, Skoczyński P, et al · · 2024 · cited 1× · PMID 39422462 · DOI 10.5603/cj.102195

Verify or expand the search:

Other trials of Pacemaker implantation

Trials testing the same drug.

NCT05021627 — Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia · NA · not yet recruiting
NCT04559646 — Application of the "Haemoblock" in Pacemaker Patients · completed
NCT04111354 — Early Mobilization After Pacemaker Implantation. · NA · completed

Other recruiting trials for Atrioventricular Block

Currently open trials in the same condition.

NCT07250529 — Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF · NA · recruiting
NCT07209852 — Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up · recruiting
NCT07276490 — Central Haemodynamics and Pacing for AV Block · NA · recruiting
NCT07464041 — Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fractio · NA · recruiting
NCT07521800 — Remote ECG Monitoring Post TAVI · NA · recruiting

Other American Heart of Poland trials

Trials by the same sponsor.

NCT07476196 — Poland-Italy Aortic Research Bridge Real World Registry · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05774262 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by American Heart of Poland
Last refreshed: 18 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05774262.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing