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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called KardiaMobile, which helps individuals with atrial fibrillation (AF) track their heart rhythm using a smartphone. The researchers aim to determine if this device can manage AF symptoms more effectively than regular care. Participants diagnosed with AF in the last six months, who own a smartphone and can use the device, may be suitable candidates. The trial will compare the frequency of doctor or hospital visits between those using the device and those who do not. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve AF management for many.

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 prior data suggests that the Kardia Mobile 6L Device is safe for atrial fibrillation patients?

Research has shown that the Kardia Mobile 6L device is safe for use. The FDA has approved this device, and it reliably tracks heart rhythms. In one study, it accurately detected atrial fibrillation, a type of irregular heartbeat. Patients generally found the device easy to use, with it correctly identifying normal heart rhythms in many cases and no major safety issues reported. Overall, evidence supports that the Kardia Mobile 6L is safe for monitoring heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kardia Mobile 6L Device for atrial fibrillation because it offers a convenient and proactive way for patients to monitor their heart health. Unlike traditional methods that rely on periodic check-ups or bulky monitoring equipment, this device syncs with a smartphone and allows users to record their ECG anytime they experience symptoms. This real-time data can be sent directly to healthcare providers, potentially leading to more timely interventions and personalized treatment adjustments. This approach could reduce unnecessary hospital visits and improve overall management of atrial fibrillation, making it a promising advancement over standard care.

What evidence suggests that the Kardia Mobile 6L Device is effective for atrial fibrillation?

Research has shown that the Kardia Mobile 6L device, which participants in this trial may receive, effectively detects atrial fibrillation (AF), a common heart rhythm issue. One study found that Kardia Mobile 6L detected AF with 100% accuracy, correctly identifying all true cases. It also demonstrated 96.4% accuracy in identifying normal heart rhythms, meaning it rarely gives false alarms. The device surpasses other personal heart monitors in spotting more types of heart rhythm problems. Its built-in AI can even predict future AF events, aiding early intervention. Overall, Kardia Mobile 6L serves as a reliable tool for monitoring heart health. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8276994/

A comparison of Kardia Mobile and standard 12-lead ... It was non-inferior for detection of atrial fibrillation and atrial flutter, showed weaker rhythm detection in pacemaker stimulation (p = 0.008), and was ...

2. alivecor.com alivecor.com/press/press_release/kardiamobile-6l-is-superior-to-one-lead-personal-devices

KardiaMobile 6L is Superior to One Lead Personal Devices It detects more arrhythmias than any other personal ECG device. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666693623000026

Artificial intelligence–enabled mobile electrocardiograms ... In this study of more than 260,000 mobile electrocardiogram (mECGs) in 73,861 AliveCor 6L users, we found that neural networks were able to predict AF events ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05407415?term=AREA%5BInterventionSearch%5D(kardia)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=6

KardiaMobile ECG Monitoring Effects on Health Care ... This is a two-center, randomized controlled trial of 100 patients comparing intervention (KardiaMobile) with standard of care. Kardia Mobile is an FDA ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11737281/

Comparative Evaluation of Consumer Wearable Devices ... The sensitivity to detect AF was 100% for all devices. The specificity to detect sinus rhythm was 96.4% (95% CI 89.5%-98.8%) for KardiaMobile 6L ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10653716/

Solutions for Atrial Fibrillation Edvocacy (SAFE) ... KardiaMobile® 6L device. Results: In 552 (82.5%) of 669 total EKG readings, a “normal” rhythm was detected, and in 117 (17.5%) EKG readings an abnormal ...

7. alivecor.com alivecor.com/products/kardiamobile6l

Kardia Mobile 6L | AliveCor Captures a 6-lead, medical-grade ECG in 30 seconds · Clear view of P, QRS, and T waves to identify atrial fibrillation, atrial flutter, and heart block · FDA- ...

8. kardia.com kardia.com/products/kardiamobile6l?srsltid=AfmBOoogKOj1GCo2J-lBKeejxvAVH_JR9ZhHH0OYFQzI8rrKUkrFseMS

EKG Monitor with 6 Leads | KardiaMobile 6L by AliveCor Heart data you can trust​​ KardiaMobile 6L is clinically validated, CE marked, and FDA-cleared, making it one of the most reliable ways to check in on your heart ...

9. isomer-user-content.by.gov.sg isomer-user-content.by.gov.sg/68/9d03e879-8726-422c-9b63-ea9ec537f149/kardiamobile-for-the-detection-of-atrial-fibrillation.pdf

KardiaMobile for the Detection of Atrial Fibrillation In both populations of patients with suspected or known AF, KM was safe, acceptable, and had good diagnostic accuracy in AF detection (both sensitivity and ...