Cardioneuroablation for treating reflex syncope and improving exercise capacity
Effects of caRdioneurOablation on Exercise perforMance in Patients With Reflex Asystolic syNcope: The Roman 3 Study
NA · Centre of Postgraduate Medical Education · NCT06440291
This study is testing a new procedure called Cardioneuroablation to see if it can help people with reflex syncope feel better and improve their ability to exercise.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Centre of Postgraduate Medical Education (other) |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06440291 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Cardioneuroablation (CNA), a novel procedure aimed at treating reflex syncope caused by vagally-induced heart rhythm issues. The research focuses on assessing the one-year outcomes of CNA on cardiorespiratory fitness in patients who experience severe symptoms due to reflex asystolic syncope. Participants will undergo CNA, which involves ablating specific nerve endings in the autonomic nervous system to prevent syncope episodes. The study will utilize cardiopulmonary exercise testing (CPET) to measure exercise capacity, a method not previously applied in this patient group.
Who should consider this trial
Good fit: Ideal candidates include individuals with severe, recurrent reflex syncope symptoms and documented asystole lasting more than 3 seconds.
Not a fit: Patients with serious comorbidities that prevent them from undergoing general anesthesia or those with non-functional heart rhythm issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of syncope episodes and improve exercise capacity for affected patients.
How similar studies have performed: While CNA has shown effectiveness in treating reflex syncope in prior studies, the specific assessment of exercise capacity using CPET in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe, recurrent symptoms due to reflex syncope or recurrent presyncope due to slow heart rate * ECG documented asystole \>3 seconds * ineffective prior non-pharmacological treatment * positive baseline atropine test (sinus rate acceleration \> 30% and no atrio-ventricular block following 2 mg of intravenous atropine) * signed written informed consent Exclusion Criteria: * serious comorbidities precluding general anaesthesia and cardioneuroablation * non-functional sinus arrest or atrio-ventricular block (negative atropine test) * lack of consent to participate in the study
Where this trial is running
Warsaw
- Department of Cardiology, Postgraduate Medical School, Grochowski Hospital — Warsaw, Poland (RECRUITING)
Study contacts
- Study coordinator: Piotr Kulakowski, PhD
- Email: kulak@kkcmkp.pl
- Phone: 604455081
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, syncope