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Kardia Mobile 6L Device for Atrial Fibrillation

N/A

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing a new way to record ECGs (KardiaMobile) to the standard of care. The new way uses a smart phone and the patient can do it themselves when they have symptoms. The trial will last 6 months and will compare how often people in each group use their device and how often they have to go to the doctor or hospital.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since KardiaMobile is a monitoring device rather than medication, it doesn't have typical drug side effects. However, there might be anxiety or discomfort from self-monitoring symptoms or potential technical issues with using the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare healthcare utilization through a questionnaire asking how many office appointments, emergency department visits, and hospital admissions they had within that 6 months.

Secondary study objectives

To compare participants healthcare-related satisfaction through a questionnaire that will ask the participants at baseline and at 6 months how satisfied they are or have been with their AF care.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Kardia Mobile GroupExperimental Treatment1 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 GroupActive Control1 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.

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