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Vasovagal Syncope | Syncope Prediction Study

Vasovagal Syncope research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Vasovagal Syncope

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Syncope PredictionAll enrolled patients that performed the tilt table test

Study Status

Completed

Start Date: November 2014

Completed Date: November 2016

Phase: N/A

Type: Observational

Design:

Primary Outcome: Number of participants with syncope recurrence predicted by VVS prediction algorithm

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: P Boon Lim, MD

Lead Sponsor: Medtronic BRC

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02140567

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