New method for treating reflex syncope using cardioneuroablation
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
NA · Centre of Postgraduate Medical Education · NCT06472102
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Centre of Postgraduate Medical Education (other) |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06472102 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with severe, recurrent reflex syncope and documented asystole lasting over 3 seconds.
Not a fit: Patients with contraindications to cardioneuroablation or computed tomography will not benefit from this study.
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 performed: While cardioneuroablation is a relatively new approach, preliminary studies have shown promise in similar methodologies, but further validation is needed.
Eligibility criteria
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 this trial is running
Warsaw, Masovian Voivodeship
- 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
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.
Conditions: Syncope, Vasovagal, cardioneuroablation, syncope