Vasovagal Syncope Clinical Trial
Official title:
Syncope Prediction Study
The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.
Vasovagal syncope (VVS) is a form of neurally-mediated reflex syncope, which is marked by a
sudden fall in blood pressure with an associated fall in heart rate often resulting in
syncope, head-up tilt (HUT) testing is commonly used to bring information about VVS using ECG
and blood pressure monitoring with medical observation.
We developed an algorithm, called Tilt Test Analyzer, to predict VVS during HUT based on the
simultaneous analysis of heart rate (RR interval), systolic blood pressure (SBP) and an
indicator of autonomic modulation represented by heart rate and blood pressure variability
(HRV and BPV).
The primary objective of this study is to evaluate the VVS prediction algorithm in a
prospective cohort of patients in the tilt laboratory The primary endpoint is the VVS
prediction algorithm performance by means of measuring the sensitivity and specificity
values.
The study is designed to test if the prospective analysis of tilt-test patients can reproduce
the results previously obtained in the published retrospective analysis on 1155 patients with
a similar clinically relevant sensitivity and specificity.
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