Kardia Mobile 6L Device for Atrial Fibrillation

Overseen By Lauren Keene

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Resting tremor, Intracardiac lead, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the trial focuses on using a device to monitor heart rhythms.

What data supports the effectiveness of the Kardia Mobile 6L Device treatment for atrial fibrillation?

The Kardia Mobile 6L Device is a handheld monitor that can produce a 6-lead ECG, which is used to detect heart rhythm problems like atrial fibrillation. It has been compared to the standard 12-lead ECG, and while there is a lack of extensive validation studies, it is part of a growing trend of mobile health solutions for managing atrial fibrillation. ^{1 2 3 4 5}

Is the Kardia Mobile 6L Device safe for use in humans?

The Kardia Mobile 6L Device is generally considered safe for use in humans, as it is FDA-approved and has been used in various studies to monitor heart rhythms. However, its safety and compatibility specifically in patients with cardiac implantable electronic devices have not been fully established. ^{1 3 5 6 7}

How is the Kardia Mobile 6L Device treatment different from other treatments for atrial fibrillation?

The Kardia Mobile 6L Device is unique because it is a handheld mobile health device that allows users to record a single-lead ECG (a test that measures the electrical activity of the heart) and detect atrial fibrillation using a smartphone app. Unlike traditional methods that require a visit to a healthcare provider, this device enables real-time monitoring and detection of heart rhythm issues at home. ^{1 2 3 8 9}

Eligibility Criteria

This trial is for adults aged 18-90 with recent atrial fibrillation, who own a smartphone and can use it to record ECGs. They should be able to live more than a year and handle the device themselves. People with implanted heart devices, resting tremors, non-English speakers, pregnant women, prisoners or those already using mobile ECG recorders cannot join.

Inclusion Criteria

Possession of a smart phone with active cell service

Physical and cognitive ability to self-record reliable ECG tracings on the KardiaMobile device

You are expected to live for more than 12 months.

Exclusion Criteria

You have a wire inside your heart.

Shaking when not moving

Non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Device Setup

Participants in the intervention arm are given a KardiaMobile device and instructed on its use

1 week

1 visit (in-person)

Monitoring and Data Collection

Participants use the KardiaMobile device to record ECGs during symptoms or as requested by healthcare providers

6 months

Follow-up

Participants are monitored for healthcare utilization and satisfaction through questionnaires

6 months

Treatment Details

Interventions

• Kardia Mobile 6L Device

Trial Overview The study tests if using the KardiaMobile device to monitor heart rhythm at home affects healthcare visits and patient experience compared to standard care. Half of the patients will get this device for free and send their heart readings to their doctors through an app.

Participant Groups

Group I: Kardia Mobile Group Experimental Treatment 1 Intervention

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 II: Standard of Care Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Cardiovascular Institute of the South Clinical Research Corporation

Collaborator

Trials

4

Recruited

220+

Findings from Research

The Alivecor Kardia Mobile device produces accurate single-lead ECG tracings in pediatric patients, showing strong agreement with standard 12-lead ECGs, making it a reliable tool for monitoring heart rhythms in children.

In a study of 30 pediatric patients, the device demonstrated a specificity of 87% for detecting atrial fibrillation, indicating it can effectively identify abnormal rhythms, although it had some false positives related to other rhythm abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can smartphone wireless ECGs be used to accurately assess ECG intervals in pediatrics? A comparison of mobile health monitoring to standard 12-lead ECG. Gropler, MRF., Dalal, AS., Van Hare, GF., et al.[2019]

The systematic review identified 208 studies on mobile health (mHealth) solutions for atrial fibrillation (AF), highlighting that diagnostic accuracy varies significantly based on the type of device (handheld, wearable, or implantable) and the technology used (like electrocardiography or photoplethysmography).

Despite the growing popularity of mHealth solutions for AF detection and management, the review emphasizes the need for further research into their clinical implications and the necessity to address barriers to their widespread adoption in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health solutions for atrial fibrillation detection and management: a systematic review. Hermans, ANL., Gawalko, M., Dohmen, L., et al.[2022]

The Kardia Mobile Cardiac Monitor (KMCM) demonstrated high accuracy in detecting atrial fibrillation (AF), with an automated algorithm showing 96.6% sensitivity and 94.1% specificity compared to physician-interpreted ECGs in a study of 52 patients.

Direct physician review of KMCM recordings significantly improved detection rates, especially for unclassified recordings, achieving 100% sensitivity, indicating that combining automated and physician interpretations can enhance diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. William, AD., Kanbour, M., Callahan, T., et al.[2022]

Mobile health devices that detect atrial fibrillation are becoming widely used and can identify more cases than traditional care, but there is ongoing debate about the appropriateness of screening, especially in younger populations.

Physicians need to be aware of the capabilities and limitations of these devices, as increased detection may lead to more referrals for genetic evaluation in younger patients with early-onset atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of digital health in detection and management of atrial fibrillation. Tooley, JE., Perez, MV.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Can smartphone wireless ECGs be used to accurately assess ECG intervals in pediatrics? A comparison of mobile health monitoring to standard 12-lead ECG. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Mobile health solutions for atrial fibrillation detection and management: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Future prospects for implantable devices for atrial defibrillation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Clinical validation and evaluation of a novel six-lead handheld electrocardiogram recorder compared to the 12-lead electrocardiogram in unselected cardiology patients (EVALECG Cardio). [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and compatibility of smart device heart rhythm monitoring in patients with cardiovascular implantable electronic devices. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Smartwatch Algorithm for Automated Detection of Atrial Fibrillation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mobile health applications for the detection of atrial fibrillation: a systematic review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Role of digital health in detection and management of atrial fibrillation. [2022]