Comparing cardioneuroablation and permanent pacing for treating bradycardia symptoms.
Official title: 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.
Run by 4th Military Clinical Hospital with Polyclinic, Poland · NCT05896592 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | 4th Military Clinical Hospital with Polyclinic, Poland Academic / other |
| Locations | 2 sites (Radom, Masovian Voivodeship and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | July 31, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | January 3, 2024 |
| Trial ID | NCT05896592 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe bradycardia, certain heart conditions, or those outside the age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AVEIR leadless pacemaker registry in the United Kingdom
This project will follow people in the UK who receive an AVEIR leadless pacemaker to see how well the device works and how safe it is over five years.
-
Cardioneuroablation for treating bradycardia
This study is testing a new procedure called cardioneuroablation to see if it can help people with slow heart rates feel better without needing a permanent pacemaker.
-
Observing patients with BIOTRONIK Implantable Cardiac Monitors
This study looks at how well the BIOMONITOR III and similar heart monitors work and keep patients safe over time.
-
Registry for implantable cardiac devices
This study is tracking how well pacemakers and defibrillators work for people with heart rhythm problems to see if they can improve patient care and outcomes.
-
Whole-body bedside ultrasound in older adults after a fall
This study tests whether doing a full-body ultrasound at the bedside changes how doctors manage older adults (65+) who come to the emergency department after a fall.
-
SPIKE FLOW endocardial pacing lead safety and performance study
This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.