Syncope Prediction Study

Completed

• Conditions: Vasovagal Syncope

• Registration Number: NCT02140567
• Lead Sponsor: Medtronic BRC

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Study Start: 2014-11
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Results First Submitted: 2017-12-01
• Results First Submitted QC: 2017-12-01
• Results First Posted: 2018-08-27
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients referred to the center with vasovagal syncope for tilt testing.
• The patient is willing and able to cooperate with the study procedures.
• The subject or legal guardian is able to provide written informed consent

Exclusion Criteria

• Patients under 18 years or over 90 years old.
• Women who are currently pregnant or have a positive pregnancy test.
• Patients who had a prior tilt test.
• Patients enrolled in another device or drug study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the Syncope Prediction Algorithm	Tilt Test with average duration of 1 hour	Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm
Specificity of the Syncope Prediction Algorithm	Tilt Test with average duration of 1 hour	Number of tilt-negative participants identified as negative by the syncope prediction algorithm

Trial Locations

Locations (1)

Hammersmith Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom