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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02140567
Other study ID # Syncope Prediction Study
Secondary ID SPS
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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