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Compares treatment options for Atrioventricular Block
Official title Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
ClinicalTrials.gov ID: NCT05774262
What this study is testing
- What it's testing
- 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)?
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written informed consent to participate in the study
- Age 18-75
- Indication (at least one) of the European Society of Cardiology (ESC) for elective pacemaker implantation due to isolated (without sinus node...
- Symptomatic first degree AVB (above 300 msec). Class IIaC
- Symptomatic Mobitz type I second degree AVB. Class IIaC
You likely can't join if
- Implanted pacemaker/ICD/CRT
- 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 and heart failure (not related to bradycardia)
See the full eligibility criteria
- Written informed consent to participate in the study
- Age 18-75
- Indication (at least one) of the European Society of Cardiology (ESC) for elective pacemaker implantation due to isolated (without sinus node dysfunction and bundle branch block) paroxysmal, persistent or reflex...
- Symptomatic first degree AVB (above 300 msec). Class IIaC
- Symptomatic Mobitz type I second degree AVB. Class IIaC
- AVB 2:1, even asymptomatic, but not during sleep. Class IIaC
- Mobitz II type advanced 2nd degree AVB or complete block (3rd degree AVB). Class IC
- Advanced AVB during AF regardless of symptoms, but not during sleep. Class IC
- Reflex syncope in patients over 40 years of age with documented pauses within the AVB mechanism, symptomatic (\>3 sec) or asymptomatic \>6 sec. Class IC
- Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism in the course of sick sinus syndrome (CSS). Class IC
- Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism during tilt test. Class IC
- Implanted pacemaker/ICD/CRT
- 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 and heart failure (not related to bradycardia)
- Status post percutaneous valvular intervention or ablation
- Acute infection or any other accompanying disease which is contraindication to percutaneous procedures and/or implantation of a pacemaker
- Pregnancy, nursing or planned pregnancy within 12 months
- Decompensated chronic diseases (endocrine disorders, electrolyte disorders, etc.)
- Advanced cardiomyopathies with indication for ICD implantation in primary or secondary prevention of sudden cardiac death (SCD)
- Advanced ventricular arrhythmias with indication for ICD implantation in primary or secondary prevention of SCD
- Persistent right or left bundle branch block
- Musculoskeletal diseases with separate indications for pacemaker implantation
- Contraindications to the procedures used in the study
- The presence of a mental illness or limitation of cognitive functions that prevent independent participation in the study, including the use of telemedicine services
- Any abnormality found that is considered by the Principal Investigator a contraindication to participate in the stidy due to data interpretation or safety issue
The study team makes the final eligibility decision.
Where it's taking place
- Dąbrowa Górnicza, Poland
- Mielec, Poland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dąbrowa Górnicza, Poland; Mielec, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.