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Completed

NCT Number: NCT02253134

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

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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Key information

Conditions

Syncope Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Palpitations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gasthuisberg Leuven, Leuven, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate the mean value of the diagnostic yield in one month

    Time frame: 1 month

    number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients

Secondary outcomes

  1. Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment

    Time frame: 1 month

  2. Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment

    Time frame: 1 month

  3. Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Acronym: ITHO04

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2014
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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