Actively Recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Led by Centre of Postgraduate Medical Education · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). Although the procedure is effective in \> 80% of patients, there are potential adverse effects associated with the lack of vagal protection. One of them is increased sinus rate and possible worsening of exercise capacity. However, it is not known how often this happens. Moreover, the most accurate tool to asses exercise capacity - cardiopulmonary exercise testing (CPET), has not yet been used in this group of patients. Therefore, the aim of the study is to assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. The study group consists of patients undergoing CNA in our institution. All patients give informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). CNA is performed according to standard protocol used in our institution. A symptom-limited cardiopulmonary exercise (CPET) is performed twice, at baseline (1-2 days before CNA) and after one year of follow-up. Standard CPET parameters are measured. Quality of life is measured using a dedicated questionnaire. Also, a control group of healthy volunteers will undergo CPET to answer the question whether subjects with reflex syncope differ in exercise capacity from healthy people.
CONDITIONS
Official Title
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe, recurrent symptoms due to reflex syncope or recurrent presyncope caused by slow heart rate
- ECG showing asystole longer than 3 seconds
- Prior non-pharmacological treatments were ineffective
- Positive atropine test with sinus rate increase over 30% and no atrio-ventricular block after 2 mg intravenous atropine
- Signed written consent to participate in the study
You will not qualify if you...
- Serious health conditions preventing general anesthesia or cardioneuroablation
- Sinus arrest or atrio-ventricular block not caused by vagal activity (negative atropine test)
- Not consenting to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Poland, 04-073
Actively Recruiting
Research Team
P
Piotr Kulakowski, PhD
CONTACT
A
Anieszka Sikorska, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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