New method for treating reflex syncope using cardioneuroablation
Official title: Value of fRagmented Atrial electrOgrams, Computed Tomography and Intracardiac Echocardiography for Identification of optiMal Sites for Radio-frequency Delivery During cArdioneuroablation for Asystolic Reflex syNcope
Run by Centre of Postgraduate Medical Education · NCT06472102 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre of Postgraduate Medical Education Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Status | Recruiting |
| Started | May 20, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT06472102 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with severe, recurrent reflex syncope and documented asystole lasting over 3 seconds.
✕Probably not a fit
Patients with contraindications to cardioneuroablation or computed tomography will 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 effectiveness of cardioneuroablation (CNA) for treating asystolic reflex syncope by comparing three methods for identifying ganglionated plexi (GP) sites in the heart. The methods include intracardiac recordings of fragmented atrial electrograms, intracardiac echocardiography, and computed tomography. A total of 100 patients with severe recurrent syncope will undergo CNA, and the study will analyze the correlation and predictive value of these identification methods for successful treatment outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients suffering from severe reflex syncope.
How similar studies have gone: While cardioneuroablation is a relatively new approach, preliminary studies have shown promise in similar methodologies, but further validation is needed.
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, especially if associated with injury, or recurrent presyncope with persistent reflex bradycardia * history of ineffective prior non-pharmacological treatment and positive baseline atropine test (sinus rate acceleration \> 30% and no AV block following 2 mg of intravenous atropine) - * informed written consent obtained Exclusion Criteria: * contraindications to perform cardioneuroablation * contraindications to perform computed tomography with intravenous contrast injection * lack of informed written consent obtained
Where it's running
-
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Masovian Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Piotr Kułakowski, 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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Treatment for reflex syncope using cardioneuroablation
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.
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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.
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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.