Clinical Trials Directory

Trials / Completed

CompletedNCT02253134

Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)

Status
Completed
Phase
Study type
Observational
Enrollment
395 (actual)
Sponsor
LivaNova · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.

Detailed description

Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients

Conditions

Timeline

Start date
2010-08-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2014-10-01
Last updated
2014-10-01

Locations

10 sites across 5 countries: Belgium, Italy, Portugal, Spain, Switzerland

Source: ClinicalTrials.gov record NCT02253134. Inclusion in this directory is not an endorsement.