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Home Monitor for AA Burden Detection IIT in TWN

Study acronym: FF108
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Jun 1, 2026 to Dec 1, 2026 Trial sites expanded: 1 → 4 locations · Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 1 entry · 1 more Show 4 more changesShow less
    • Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators: details revised at 1 of 1 entry
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary Endpoint: * Early detection rate in Atrial Arrhythmia (AA) burden * Data transmission success rate for overall number of atrial burden collection during the monitoring period Secondary Endpoints: * Atrial burden occurrence at 3/6/12 months post-aATP * Incidence of arrhythmia * Safety: Immediate (\< 24 hours), in-hospital, 3 months, 6 months and 12 months adverse events
Trial Details
NCT Number NCT07572279
Lead Sponsor National Taiwan University Hospital
Collaborators: Biotronik SE & Co. KG
Conditions Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov