Treatment for reflex syncope using cardioneuroablation
Official title: Acute electRophysiOlogical Changes of Ventricular Myocardium Following cArdioneuroablatioN for Asystolic Reflex Syncope
Run by Centre of Postgraduate Medical Education · NCT06458140 · Data updated 2026-11-12
This study is testing if a new procedure called cardioneuroablation can help people with severe reflex syncope by improving their heart function and reducing fainting episodes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Centre of Postgraduate Medical Education Academic / other |
| Locations | 1 site (Warsaw) |
| Status | Recruiting |
| Started | May 20, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | May 14, 2025 |
| Trial ID | NCT06458140 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with severe, recurrent reflex syncope and documented asystole lasting more than 3 seconds.
✕Probably not a fit
Patients who do not consent to participate or have contraindications for right ventricular stimulation 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 study investigates the effects of cardioneuroablation (CNA) on patients suffering from severe reflex syncope characterized by asystolic episodes. CNA aims to eliminate the vagal nerve's influence on heart function, potentially improving heart rate and conduction. The study will assess the acute impacts of total vagal denervation on ECG and electrophysiological parameters, as well as the risk of ventricular arrhythmias in 50 patients undergoing the procedure. Measurements will be taken before and after the CNA intervention to evaluate its effectiveness and safety.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of syncope episodes in affected patients.
How similar studies have gone: While cardioneuroablation is a relatively novel approach, preliminary studies suggest it may hold promise in treating similar conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe, recurrent symptoms due to reflex syncope with ECG documented asystole \>3 seconds * history of ineffective prior non-pharmacological treatment * positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine) * informed written consent to participate in the study Exclusion Criteria: * Lack of consent to participate in the study * Contraindications to perform right ventricular stimulation
Where it's running
-
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland Recruiting
Study contacts
- Study coordinator: Piotr Kulakowski, MD PhD
- Email: kulak@kkcmkp.pl
- Phone: +48 22 5152757
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias
This study tests whether focal cryoablation can treat vagally driven slow heart rhythms as well as traditional radiofrequency ablation in adults with bradycardia or related syncope.
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New method for treating reflex syncope using cardioneuroablation
This study is testing a new heart treatment called cardioneuroablation to see which of three methods works best for finding the right spots in the heart to help people with severe fainting spells.
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Understanding how blood phobia affects fainting
This study is testing how a fear of blood and needles affects fainting by looking at how people's bodies respond when they feel stressed about these things.
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Registry for cardioneuroablation in patients with recurrent vasovagal syncope
This study is collecting information to see how well a new treatment called cardioneuroablation works for people with frequent fainting spells caused by vasovagal syncope.
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Improving blood pressure control in children who faint
This study is testing if certain movements can help children aged 6-18 who faint feel better by improving their blood pressure and heart function compared to regular advice.
-
Assessing counterpressure maneuvers for preventing fainting in children
This study is testing if teaching children techniques to prevent fainting can help them avoid losing consciousness when they visit the emergency room.
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.