Develop and Validate Machine-Learning Algorithm to Detect Atrial Fibrillation with Wearable Devices

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Observational
SUMMARY

Atrial Fibrillation (AF) is an abnormal heart rhythm. Because AF is often asymptomatic, it often remains undiagnosed in the early stages. Anticoagulant therapy greatly reduces the risks of stroke in patients diagnosed with AF. However, diagnosis of AF requires long-term ambulatory monitoring procedures that are burdensome and/or expensive. Smart devices (such as Apple or Fitbit) use light sensors (called photoplethysmography or PPG) and motion sensors (called accelerometers) to continuously record biometric data, including heart rhythm. Smart devices are already widely adopted. This study seeks to validate an investigational machine-learning software (also called algorithms) for the long-term monitoring and detection of abnormal cardiac rhythms using biometric data collected from consumer smart devices. The research team aims to enroll 500 subjects who are being followed after a stroke event of uncertain cause at the Emory Stroke Center. Subjects will undergo standard long-term cardiac monitoring (ECG), using FDA-approved wearable devices fitted with skin electrodes or implantable continuous recorders, and backed by FDA-approved software for abnormal rhythm detection. Patients will wear a study-provided consumer wrist device at home, for the 30 days of ECG monitoring, 23 hours a day. At the end of the 30 days, the device data will be uploaded to a secure cloud server and will be analyzed offline using proprietary software (called algorithms) and artificial intelligence strategies. Detection of AF events using the investigational algorithms will be compared to the results from the standard monitoring to assess their reliability. Attention will be paid to recorded motion artifacts that can affect the quality and reliability of recorded signals. The ultimate aim is to establish that smart devices can potentially be used for monitoring purposes when used with specialized algorithms. Smart devices could offer an affordable alternative to standard-of-care cardiac monitoring.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• Adults 55 years of age or older.

• Post-discharge with diagnostic of index ischemic stroke with uncertain cause.

• Subject must be treated at the Emory Stroke Clinic for follow-up treatment.

• Subject must be prescribed a clinical extended cardiac monitoring.

• Subject or their Legal Authorized Representative (LAR) must be willing and able to provide informed consent.

• Subject, family proxy, or caregiver must understand English and the instructions to manage and recharge the study wrist device.

Locations
United States
Georgia
Emory Clinic
RECRUITING
Atlanta
Contact Information
Primary
Xiao Hu, PhD
xhu40@emory.edu
404-712-8520
Backup
Corey Williams
corey.williams2@emory.edu
404-251-4060
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2028-12
Participants
Target number of participants: 500
Treatments
AFib monitoring learning algorithms
Participants will wear a prescribed (standard of care) ambulatory ECG monitoring (Biotel Patch or LINQ insertable cardiac monitor) and either a MOTO 360 smartwatch, fitted with proprietary firmware (LifeQ) to collect continuous biometric signals, including PPG signals and 3-axis accelerometers in an ambulatory setting or a Samsung Galaxy watch 6 paired with the Samsung Galaxy phone S21 to continuously record PPG and/or ECG data that can transmit data.
Related Therapeutic Areas
Sponsors
Collaborators: Duke University, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Emory University

This content was sourced from clinicaltrials.gov