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

LivaNova

Status: Completed

Conditions: Palpitations; Syncope

Study type: Observational

Funder types: Industry

Identifiers

NCT02253134

SYNARR-FLASH STUDY - ITHO04

Details and patient eligibility

About

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.

Full description

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

Enrollment: 395 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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