Treatment for reflex syncope using cardioneuroablation
Acute electRophysiOlogical Changes of Ventricular Myocardium Following cArdioneuroablatioN for Asystolic Reflex Syncope
NA · Centre of Postgraduate Medical Education · NCT06458140
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Centre of Postgraduate Medical Education (other) |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06458140 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with severe, recurrent reflex syncope and documented asystole lasting more than 3 seconds.
Not a fit: Patients who do not consent to participate or have contraindications for right ventricular stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of syncope episodes in affected patients.
How similar studies have performed: While cardioneuroablation is a relatively novel approach, preliminary studies suggest it may hold promise in treating similar conditions.
Eligibility criteria
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 this trial is running
Warsaw
- 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
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, reflex syncope, ventricular arrhythmia