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Cardioneuroablation for Reflex Syncope

Centre of Postgraduate Medical Education · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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nasyncope
Aim. To assess the effects of cardioneuroablation (CNA) on cardiac autonomic regulation and syncope recurrences in patients with vasovagal syncope (VVS), and to compare this novel approach with standard non-pharmacological treatment. Measurements. 1. Before CNA: 1. Detailed history taking and assessment of eligibility 2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval 3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment 4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt). 5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value 6. Assessment of quality of life using the SF-36 questionnaire 7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA 2. During CNA: 1. Heart rate before and immediately after CNA 2. Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP. 3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA 4. Atropine test (2 mg) will be repeated immediately after CNA. 3. After CNA: 1. 1-2 days after CNA standard ECG 2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control of ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire Anticipated results. 1. CNA performed with technique u
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