Clinical trial NCT02253134: Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
Official title: Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Palpitations
Keywords: Syncopal events
Palpitation events
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that present unexplained Syncope and/or palpitations events of a suspected arrhythmic origin

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the mean value of the diagnostic yield in one month
timeFrame: 1 month
Secondary outcomes:
measure: Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment
timeFrame: 1 month
measure: Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment
timeFrame: 1 month
measure: Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)
timeFrame: 1 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Lavagna
country: Italy
facility: Az. Sanit. Locale N. 4 Chiavarese
city: Milano
country: Italy
facility: Ospedale Niguarda Ca Granda
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Bern
country: Switzerland
facility: Universitätsklinik für Kardiologie Inselspital
Study officials:
affiliation: Azienda Ospedaliera Niguarda Ca' Granda - Milano
name: Emanuela T Locati
role: PRINCIPAL_INVESTIGATOR
References: