N/A
N=140
Syncope Prediction Study
Vasovagal Syncope
Bottom Line
View on ClinicalTrials.gov: NCT02140567 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Sensitivity of the Syncope Prediction Algorithm — 81; 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic BRC
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of the Syncope Prediction Algorithm |
81; 2 | — |
| PRIMARY Specificity of the Syncope Prediction Algorithm |
45; 6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02140567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.