Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Sponsor
- Wroclaw Medical University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in degree of parasympathetic denervation (%)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Piotr Niewinski, MD
MD, PhD
Wroclaw Medical University
Eligibility Criteria
Inclusion Criteria
- •signed informed consent
- •sinus rhythm
- •clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope
Exclusion Criteria
- •pregnancy
- •known atropine hypersensitivity
Outcomes
Primary Outcomes
Change in degree of parasympathetic denervation (%)
Time Frame: 12 months
Secondary Outcomes
- 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)