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KardiaMobile ECG Monitoring Effects on Health Care Utilization and Patient Experience With Atrial Fibrillation

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2025 → Dec 2026
See other at-risk trials from Northwestern University

Record History

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  1. Notable Primary and study completion pushed from Dec 2025 to Dec 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Notable Primary and study completion dates: Dec 2024 to Dec 2025v5
  3. Notable Primary and study completion dates: Dec 2023 to Dec 2024v4
  4. Minor Trial status: Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Sep 2022 to Sep 1, 2022
    • Site details revised
    v3
  5. Notable Primary and study completion dates: Dec 2022 to Dec 2023
    • Start date: Jun 2022 to Sep 2022
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a two-center, randomized controlled trial of 100 patients comparing intervention (KardiaMobile) with standard of care. Kardia Mobile is an FDA approved device that allows one- or six lead ECG recording for 30 seconds using the patient's smart phone. The device has a automated algorithm that interprets the ECG as either sinus rhythm, AF, or unclassified. The intervention arm will be given a KardiaMobile device, free of charge, to be synched to their smartphone at the time of enrollment. They will be instructed on proper device procedure and will use the device with the onset of potential AF-related symptoms (e.g. chest pressure, palpitations, lightheadedness, syncope, shortness of breath, or other symptoms concerning for a cardiac etiology) or when requested to do so by their healthcare provider. The device ECG recordings will be transmitted to participants physicians through MyChart who will incorporate this information into the patient's treatment as indicated. All files will be stored on a private, secure platform and any subsequent communication from the clinical team will occur via standard clinical channels (MyChart or telephone contact). Healthcare utilization will be assessed by having the participants in both groups complete a questionnaire asking how many times they used their KardiaMobile device (if randomized to this group) and how many office appointments, emergency department visits, and hospital admissions they had within that six-month period.
Trial Details
NCT Number NCT05407415
Lead Sponsor Northwestern University
Collaborators: Cardiovascular Institute of the South Clinical Research Corporation
Conditions
(from sponsor)
Atrial Fibrillation (AF)
Related terms Atrial Fibrillation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov