About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Cardioneuroablation
Procedure/SurgeryCardioneuroablation procedure performed according to the protocol
Treatment groups
Trial outcomes
Primary outcomes
peak Vo2
peak Vo2 = maximum amount of oxygen that body can absorb and use during exercise (ml/kg/min)
Secondary outcomes
chronotropic index
(peak heart rate-resting heart rate)/(220-age-resting heart rate) (%)
METs
metabolic equivalent of task (kcal/kg/min)
HR peak
maximal heart rate during exercise (beats/min)
HR reserve
heart rate reserve = the difference between peak heart rate during exercise and heart rate soon after stopping exercise.
Other outcomes
Quality of Life
The Impact of Syncope on Quality-of-Life Questionnaire University of Calgary (points)
Sponsors and contacts
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