Syncope Prediction Study
SPS
2 other identifiers
observational
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
August 27, 2018
CompletedMarch 15, 2019
February 1, 2019
1.9 years
April 30, 2014
December 1, 2017
February 22, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Syncope Prediction
All enrolled patients that performed the tilt table test
Eligibility Criteria
Vasovagal syncope patients
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic BRClead
Study Sites (1)
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Related Publications (1)
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.
PMID: 29715516DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Phang Boon Lim
- Organization
- Imperial College Healthcare NHS Trust in London, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
P Boon Lim, MD
Hammersmith Hospital, Imperial College Healthcare NHS Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2014
First Posted
May 16, 2014
Study Start
November 1, 2014
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
March 15, 2019
Results First Posted
August 27, 2018
Record last verified: 2019-02