Syncope Prediction Study

Vasovagal Syncope Clinical Trial

— SPS  

Official title:

Syncope Prediction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140567
• Other study ID #: Syncope Prediction Study
• Secondary ID: SPS
• Status: Completed
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2019
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal
• Vasovagal Syncope

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital, Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the Syncope Prediction Algorithm	Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm	Tilt Test with average duration of 1 hour
Primary	Specificity of the Syncope Prediction Algorithm	Number of tilt-negative participants identified as negative by the syncope prediction algorithm	Tilt Test with average duration of 1 hour