Syncope Prediction Study (SPS)

Medtronic

Status: Completed

Conditions: Vasovagal Syncope

Study type: Observational

Funder types: Industry

Identifiers

NCT02140567

Syncope Prediction Study

SPS (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 1 patient group

Syncope Prediction

Description:

All enrolled patients that performed the tilt table test