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

Syncope Clinical Trial

— ITHO04  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253134
• Other study ID #: SYNARR-FLASH STUDY - ITHO04
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: September 30, 2014
• Start date: August 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeSwitzerland: Ethics CommetteeBelgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Palpitations
• Syncope

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg Leuven	Leuven
Italy	Az. Sanit. Locale N. 4 Chiavarese	Lavagna
Italy	Ospedale Niguarda Ca Granda	Milano
Portugal	Hospital de Santa Marta	Lisboa
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Institut Universitari Dexeus	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Universitätsklinik für Kardiologie Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

Belgium,  Italy,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the mean value of the diagnostic yield in one month	number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients	1 month	No
Secondary	Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment		1 month	No
Secondary	Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment		1 month	No
Secondary	Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)		1 month	No