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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

395 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Syncope Palpitations

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Syncope and/or palpitations events occurred in the last 30 days
* Events likely of arrhythmic origin
* No conclusive diagnosis established yet
* High probability of episodes recurrence (presence of at least one previous event in the last 12 months)
* Patient has signed the consent to participate to the study and/or to data treatment

Exclusion Criteria

* Inability to understand the purpose of the study or refusal to cooperate
* Expected low compliance with the recording technique.
* Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit)
* Already included in other competitor clinical study
* Under guardianship
* Age less than 18

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No