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โ† Trials
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Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.

RecruitingNAAges 18 Years - 65 YearsAll4th Military Clinical Hospital with Polyclinic, Pโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM). Although PM remains the main therapeutic approach for most patients with SND/AVB, long-term PM therapy can be associated with various limitations, complications, and the need for device and electrode replacement. There is increasing evidence for the effectiveness of an alternative approach to functional bradycardia associated with excessive vagal activation - cardioneuroablation (CNA). The method leads to the alleviation or complete resolution of bradycardia symptoms, as well as reflex syncope, providing an opportunity to discontinue PM therapy. Primary aims 1.Evaluation of the efficacy and safety of CNA as a therapy allowing for discontinuation of PM therapy in patients with SND or AV

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients who underwent pacemaker implantation before 50 years old due to sinus node and/or atrioventricular node dysfunction * Positive response to atropine test * Age between 18-65 years * Signed informed consent to participate in the study Exclusion Criteria: * Own heart rate \<30/min * Fainting after pacemaker therapy initiation * Persistent and sustained atrial fibrillation * History of myocarditis * History of myocardial infarction * History of cardiac surgery * History of ablation procedures * Congenital heart defects * Congenital atrioventricular block * Neuromuscular and neurodegenerative diseases * Indications for expanding the pacemaker system to ICD/CRT-D * Pregnancy * Renal insufficiency with GFR \<30 ml/min/1.73m2 * Age below 18 and above 65 years * HAS-BLED score \>/= 3 points
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What it tests

  • Invasive electrophysiological study
  • Extracardiac vagal stimulation
  • Cardioneuroablation
  • Redo cardioneuroablation
  • Implantation of the implantable loop recorder
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Where

2 sites
Mazowiecki Specialist Hospital
Radom, Poland
Medical University of Silesia
Katowice, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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