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

NCT02253134 | Completed

• 1 other identifier: SYNARR-FLASH STUDY - ITHO04
• Study Type: observational
• Target: 395
• Locations: 5 countries
• Sites: 10

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.

Conditions

Syncope; Palpitations

Keywords

Syncopal events; Palpitation events

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that present unexplained Syncope and/or palpitations events of a suspected arrhythmic origin

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LivaNova: lead

Study Sites (10)

UZ Gasthuisberg Leuven

Leuven, 3000, Belgium

Location

Az. Sanit. Locale N. 4 Chiavarese

Lavagna, 16033, Italy

Location

Ospedale Niguarda Ca Granda

Milan, 20162, Italy

Location

Hospital de Santa Marta

Lisbon, Portugal

Location

Institut Universitari Dexeus

Barcelona, 08028, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Universitätsklinik für Kardiologie Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

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

Study Officials

• Emanuela T Locati

  Azienda Ospedaliera Niguarda Ca' Granda - Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: October 1, 2014
• Study Start: August 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

CH (1); ES (5); IT (2); BE (1); PT (1)