Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH) (ITHO04)

September 30, 2014 updated by: LivaNova
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

395

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg Leuven
  • Italy
      • Lavagna, Italy, 16033
        • Az. Sanit. Locale N. 4 Chiavarese
      • Milano, Italy, 20162
        • Ospedale Niguarda Cà Granda
  • Portugal
      • Lisboa, Portugal
        • Hospital De Santa Marta
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain, 08028
        • Institut Universitari Dexeus
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitätsklinik für Kardiologie Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the mean value of the diagnostic yield in one month
Time Frame: 1 month
number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Emanuela T Locati, Azienda Ospedaliera Niguarda Ca' Granda - Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNARR-FLASH STUDY - ITHO04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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