Clinical trial NCT02140567: Syncope Prediction Study
Official title: Syncope Prediction Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vasovagal Syncope
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vasovagal syncope patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of the Syncope Prediction Algorithm
timeFrame: Tilt Test with average duration of 1 hour
measure: Specificity of the Syncope Prediction Algorithm
timeFrame: Tilt Test with average duration of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: Hammersmith Hospital, Imperial College Healthcare NHS Trust
name: P Boon Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Virag N, Erickson M, Taraborrelli P, Vetter R, Lim PB, Sutton R. Predicting vasovagal syncope from heart rate and blood pressure: A prospective study in 140 subjects. Heart Rhythm. 2018 Sep;15(9):1404-1410. doi: 10.1016/j.hrthm.2018.04.032. Epub 2018 Apr 30.