Comparing cardioneuroablation and permanent pacing for treating bradycardia symptoms.
A Multicenter, Randomized, Double-blind, Research Study comparinG the Efficacy and Safety of cardioneuroablaTion vs Permanent Pacing in Patients With an implantabLE PACEmaker for Symptomatic Bradycardia.
This study is testing if a new treatment called cardioneuroablation can help people with slow heart rates feel better and possibly stop using their pacemakers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | 4th Military Clinical Hospital with Polyclinic, Poland Academic / other |
| Locations | 2 sites (Radom, Masovian Voivodeship and 1 other locations) |
| Trial ID | NCT05896592 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of cardioneuroablation (CNA) as an alternative to permanent pacemaker (PM) therapy in patients suffering from symptomatic bradycardia due to sinus node dysfunction or atrioventricular block. Participants will be randomized into groups receiving either CNA or continued PM therapy, with assessments including ECG monitoring, symptom history, and device checks over several months. The study aims to determine if CNA can effectively alleviate symptoms and allow for the discontinuation of PM therapy, potentially improving patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have undergone pacemaker implantation for sinus node or atrioventricular node dysfunction and have a positive response to the atropine test.
Not a fit: Patients with severe bradycardia, certain heart conditions, or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide patients with a non-invasive option to manage bradycardia symptoms and reduce reliance on permanent pacemakers.
How similar studies have performed: While the use of cardioneuroablation is gaining attention, this specific comparison with permanent pacing is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Radom, Masovian Voivodeship and 1 other locations
- Mazowiecki Specialist Hospital — Radom, Masovian Voivodeship, Poland (Recruiting)
- Medical University of Silesia — Katowice, Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Przemyslaw Skoczynski, PhD — 4th Military Clinical Hospital with Polyclinic, Poland
- Study coordinator: Przemyslaw Skoczynski, PhD
- Email: przemyslaw.skoczynski@umed.wroc.pl
- Phone: 48602753043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.