Syncope, Vasovagal, Neurally-Mediated
Conditions
Brief summary
Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.
Interventions
PROCEDURECardioneuroablation
Ablation of parasympathetic ganglia of the heart
Sponsors
Wroclaw Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* signed informed consent * sinus rhythm * clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope
Exclusion criteria
* pregnancy * known atropine hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in degree of parasympathetic denervation (%) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in heart rate (beats/min) | 12 months |
| Change in heart rate variability (ms) | 12 months |
| Change in cardiac barosensitivity (ms/mmHg) | 12 months |
| Change in hypoxic heart rate response (beats/min SpO2) | 12 months |
| Time to recurrence of syncopal event (days | 12 months |
Countries
Poland
Outcome results
None listed