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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02253134

Acronym

ITHO04

Enrollment

395

Registered

2014-10-01

Start date

2010-08-31

Completion date

2013-06-30

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palpitations, Syncope

Keywords

Syncopal events, Palpitation events

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment	1 month
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

Countries

Belgium, Italy, Portugal, Spain, Switzerland

Outcome results