Actively Recruiting
Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
Led by American Heart of Poland · Updated on 2024-03-18
300
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent to participate in the study
- Age 18-75 years
- Indication for elective pacemaker implantation according to ESC guidelines for isolated paroxysmal, persistent, or reflex atrioventricular block including symptomatic first degree AVB (above 300 msec), symptomatic Mobitz type I second degree AVB, AVB 2:1 not during sleep, Mobitz II advanced 2nd degree AVB or complete block, advanced AVB during atrial fibrillation not during sleep, and reflex syncope in patients over 40 years with documented pauses within AVB mechanism
You will not qualify if you...
- Implanted pacemaker, ICD, or CRT device
- Sinus node dysfunction with indication for pacemaker implantation
- Planned ablation of the atrioventricular junction
- Severe prolonged bradycardia in advanced AVB requiring intravenous drugs and temporary pacing
- Status post cardiac surgery
- Acute myocardial infarction or heart failure unrelated to bradycardia
- Status post percutaneous valvular intervention or ablation
- Acute infection or other contraindications to percutaneous procedures or pacemaker implantation
- Pregnancy, nursing, or planned pregnancy within 12 months
- Decompensated chronic diseases such as endocrine or electrolyte disorders
- Advanced cardiomyopathies or ventricular arrhythmias requiring ICD implantation
- Persistent right or left bundle branch block
- Musculoskeletal diseases with separate indications for pacemaker implantation
- Contraindications to study procedures
- Mental illness or cognitive limitations preventing participation or telemedicine use
- Any other abnormalities considered contraindications by the Principal Investigator due to safety or data interpretation concerns
AI-Screening
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Trial Site Locations
Total: 2 locations
1
American Heart of Poland
Dąbrowa Górnicza, Poland, 41-300
Actively Recruiting
2
American Heart of Poland
Mielec, Poland, 39-300
Actively Recruiting
Research Team
S
Sebastian M Stec, MD, PhD
CONTACT
E
Edyta Stodolkiewicz-Nowarska, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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