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

Last updated: April 29, 2025
Sponsor: Northwestern University
Overall Status: Active - Enrolling

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

Kardia Mobile 6L Device

Clinical Study ID

NCT05407415
STU00216514
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-90 years of age,

  • Diagnosis of atrial fibrillation within the last 6 months,

  • Possession of a smart phone with active cell service,

  • Physical and cognitive ability to self-record reliable ECG tracings on theKardiaMobile device,

  • Life expectancy >12 months.

Exclusion

Exclusion Criteria:

  • Resting tremor

  • Has an intracardiac lead.

  • Has an implanted loop recorder.

  • Already has an apple watch, FitBit, or other mobile ECG recorder.

  • Those who are non-English speaking, pregnant, or a prisoner.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Kardia Mobile 6L Device
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.