"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)" "CRYPTONITE"

Recruiting

Phase N/A Results N/A

Trial Description

STUDY TYPE:
Prospective, national , multicenter, and observational study.
OBJECTIVE:
To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.
DEVICE:
Reveal XT 9529 (SQDM)
SAMPLE SIZE AND STUDY DURATION:
100 patients enrolled which will be followed during a period of 2 years.

Detailed Description

Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation

Outcomes

Type Measure Time Frame Safety Issue
Primary First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes. Patients will be followed up during two years, regardless of reaching or not the primary endpoint. No
Secondary All subsequent AF episodes detected by the ILR after primary outcome (AF burden) Patients will be followed up during two years No
Secondary AF episodes detected by external monitoring Patients will be followed up during two years No
Secondary Presence of stroke, recurrent TIA, or silent infarction in neuroimaging Patients will be followed up during two years No
Secondary Changes in anticoagulant therapy Patients will be followed up during two years No

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