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

NCT ID: NCT05407415

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Atrial Fibrillation (AF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Kardia Mobile Group

The intervention arm will be given a KardiaMobile device 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 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.

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.

Group Type: EXPERIMENTAL

Kardia Mobile 6L Device

Intervention Type: OTHER

The KardiaAL is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible fonnats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.

The KardiaAI library provides the following capabilities:

• ECG noise filtering,
• heart rate measurement from ECGs,
• detection of noisy ECGs, and
• ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician).

Standard of Care Group

The standard of care group will follow their routine care for their atrial fibrillation.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kardia Mobile 6L Device

The KardiaAL is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible fonnats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.

The KardiaAI library provides the following capabilities:

• ECG noise filtering,
• heart rate measurement from ECGs,
• detection of noisy ECGs, and
• ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician).

Intervention Type: OTHER

Eligibility Criteria

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 the KardiaMobile device,
• Life expectancy >12 months.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardiovascular Institute of the South Clinical Research Corporation

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Rod Passman

Clinical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00216514

Identifier Type: -

Identifier Source: org_study_id