NCT05407415Enrolling by invitation
KardiaMobile ECG Monitoring Effects on Health Care Utilization and Patient Experience With Atrial Fibrillation
Smartphone-based KardiaMobile ECG Monitoring Effects on Health Care Utilization and Patient Experience With Atrial Fibrillation: A Pilot Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 May 2022
- Start date
- 1 Sept 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Northwestern University
- Diseases
- Atrial fibrillation
- NCT number
- NCT05407415
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Sept 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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 the KardiaMobile device,
- Life expectancy \>12 months.
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.