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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05774262
Other study ID # 2022/ABM/03/00035
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source American Heart of Poland
Contact Sebastian M Stec, MD, PhD
Phone +48 600-298-022
Email smstec@wp.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pacemaker implantation
Elective pacemaker implantation (DDDR) for functional AVB according to the 2021 ESC Guidelines for Cardiac Pacing
Cardioneuroablation (CNA)
Experimental method; elective implantable loop recorder (ILR) and biatrial, binodal, atomically and electroanatomically guided CNA with extracardiac vagal nerve stimulation (ECVS) prior and after procedure monitoring (disappearance of ECVS-induced AVB with the goal of achieving post-procedure and maintaining a target heart rate > 50 beats per minute). CNA procedure is performed with radio-frequency generators and irrigated catheters and with support of 3D-electroanatomic mapping system. CNA group will receive external ECG recorders. The major reason for external ECG recorders is to provide documentation of clinical AVB, as well as monitoring of patients before and after CNA (or PM implantation, if accepted). In case of severe AVB symptoms always the emergency system will be called.

Locations

Country Name City State
Poland American Heart of Poland Dabrowa Górnicza
Poland American Heart of Poland Mielec

Sponsors (1)

Lead Sponsor Collaborator
American Heart of Poland

Country where clinical trial is conducted

Poland, 

References & Publications (21)

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Outcome

Type Measure Description Time frame Safety issue
Primary To determine the efficacy of CNA in the treatment of AVB in comparison to PM therapy within 12 months of PM implantation/CNA procedure. This is objective endpoint examining the onset of AVB episodes after PM/CNA. It will specify the number of pauses > 3.0 s in the ECG external recorder for group B (occurrence of > 1 pause or the need for earlier (0-12 months) PM implantation will be an indicator of the failure of the CNA procedure), assuming the presence of PM stimulation in group A at the level between 93-100% (equates to the continued duration of the AVB treated with PM). 12 months
Secondary Occurrence of MACE (major advers cardiac events) MACE are defined as peri-procedural and long-term complications: death, stroke, myocardial infarction, pericardial effusion requiring drainage, AVB, venous thrombosis, infection, hemorrhage, hematoma, fistula, pseudoaneurysm, surgical intervention at 0, 3, 6, 12 months
Secondary Assessment of the effect of CNA and PM implantation on AVB symptoms based on based on VAS (Visual Analog Scale) VAS (Visual Analog Scale) indicates the general health status with100 indicating the best health, 0 indicating the worst health status. 0, 3, 6, 12 months
Secondary Assessment of the effect of CNA and PM implantation on health-related quality of life (QOL) based on questionaire EQ-5D-5L EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1-5 ponts, that describes the patient's health state. The maximum score of 1 indicates the best health state, higher scores indicate more severe or frequent problems. 0, 6, 12 months
Secondary Assessment of the effect of CNA and PM implantation on health-related quality of life (QOL) based on questionaire SF-36 SF-36 questionnaire consists of 36 questions that are distributed across eight scales. Each scale is directly transformed into 0-100 scale. The lower the score the more disability, the higher the score the less disability. 0, 6, 12 months
Secondary Assessment of the effect of CNA and PM implantation on fatique based on Modified Fatigue Impact Scale (MFIS) MFIS is a validated, standardized, 21-item questionnaire, which provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Total scores range from 0-84. The lower the score the less fatigue, the higher the score the more fatigue impairs physical, cognitive, and psychosocial functioning. 0, 6, 12 moths
Secondary Assessment of the effect of CNA and PM implantation on depression/anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M) HADS-M is a validated, standardized 16-item questionnaire to evaluate the association between anxiety and depression and the degree of illness acceptance in patients. Total scores range from 0-64. Higher scores indicate a greater degree of anxiety or depression. 0, 6, 12 months
Secondary Assessment of the effect of CNA and PM implantation on sleep disorders based on questionaire Epworth Sleep Scale (ESS) The ESS score is a standardized, validated 8-item questionnaire (with scores 0-3 each). The total score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. 0, 6, 12 months
Secondary Assessment of the effect of CNA and PM implantation on sleep disorders based on Athens Insomnia Scale-8 (AIS-8) AIS-8 is a standardized, validated questionnaire assessing 8 factors related to nocturnal sleep and daytime dysfunction, which are rated on a 0-3 scale. The sleep is evaluated from the cumulative score of all factors and reported as an individual's sleep outcome. Higher score indicates more sleep disturbances. 0, 6, 12 months
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