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Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity

Not Applicable
Completed
Conditions
Syncope, Vasovagal, Neurally-Mediated
Registration Number
NCT06697145
Lead Sponsor
Wroclaw Medical University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria
  • signed informed consent
  • sinus rhythm
  • clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope
Exclusion Criteria
  • pregnancy
  • known atropine hypersensitivity

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Change in degree of parasympathetic denervation (%)12 months
Secondary Outcome Measures
NameTimeMethod
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 (days12 months
Change in heart rate variability (ms)12 months
Change in heart rate (beats/min)12 months

Trial Locations

Locations (1)

Wroclaw Medical University

🇵🇱

Wroclaw, Dolnoslaskie, Poland

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