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

Completed

• Conditions: Syncope; Palpitations

• Registration Number: NCT02253134
• Lead Sponsor: LivaNova

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

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-07-10
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Study First Posted: 2014-10-01
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the mean value of the diagnostic yield in one month	1 month	number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients

Secondary Outcome Measures

Name	Time	Method
Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment	1 month
Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)	1 month
Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment	1 month

Trial Locations

Locations (10)

UZ Gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

Hospital de Santa Marta; 🇵🇹 Lisboa, Portugal

Universitätsklinik für Kardiologie Inselspital; 🇨🇭 Bern, Switzerland

Az. Sanit. Locale N. 4 Chiavarese; 🇮🇹 Lavagna, Italy

Ospedale Niguarda Ca Granda; 🇮🇹 Milano, Italy

Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain