Status:
COMPLETED
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
Lead Sponsor:
LivaNova
Conditions:
Syncope
Palpitations
Eligibility:
All Genders
18+ years
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...
Detailed Description
Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT02253134
Start Date
August 1 2010
End Date
June 1 2013
Last Update
October 1 2014
Active Locations (10)
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1
UZ Gasthuisberg Leuven
Leuven, Belgium, 3000
2
Az. Sanit. Locale N. 4 Chiavarese
Lavagna, Italy, 16033
3
Ospedale Niguarda Ca Granda
Milan, Italy, 20162
4
Hospital de Santa Marta
Lisbon, Portugal