DELTA (Detecting and Predicting Atrial Fibrillation in Post-Stroke Patients)

RecruitingOBSERVATIONAL
Enrollment

500

Participants

Timeline

Start Date

March 21, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Stroke, Ischemic
Interventions
DEVICE

wearable wristband model

MOTO 360 smartwatch: is a specific consumer wearable wristband model (Motorola: MOTO 360), fitted with proprietary firmware (LifeQ) to collect continuous biometric signals, including PPG signals and 3-axis accelerometers in an ambulatory setting. The device is not a medical or diagnostic device, but rather a photoplethysmography (PPG) data collection device. PPG is a non-invasive technology that uses light to measure the change in the volume of blood beneath the skin that occurs as the heart beats. LifeQ has developed software that enables the collection of vital signs data from PPG technology.

OTHER

Samsung Galaxy Watch 6

"The Samsung Galaxy Watch6 will collect study data on physiological signals with a compatible Samsung Galaxy phone S21. The Samsung Galaxy Watch6 will include various models, the difference being the size of the watch face or the analog front end of the device.~The software device is installed on the Samsung Galaxy Watch. The app on the watch continuously records PPG and/or ECG data and transmits it. The phone app allows study staff to enter the subject ID, initiate data collection, and stop data collection sessions on the watch. It also receives and stores PPG and ECG data from the paired watch. The PPG app used in the study does not trigger irregular rhythm notifications or display rhythm classification. The data collected using the PPG app will support algorithm development."

DEVICE

Standard of care extended ECG monitoring

Participants enrolled in the study are prescribed ambulatory ECG monitoring (Mobile Cardiac Outpatient Telemetry, Biotel e-Patch, or LINQ insertable cardiac monitor). If the patient is negative for Afib during their time wearing an ECG monitoring patch, then patients may proceed with LINQ insertable cardiac monitor, as part of their standard of care. These are standard-of-care FDA-approved devices and detection software. Researchers will rely on the final ECG report to identify arrhythmic events to use as a golden standard to evaluate the algorithm findings. Specifically, the raw data will be used for establishing and getting an accurate ground truth for the algorithm.

Trial Locations (1)

30322

RECRUITING

Emory Clinic, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Emory University

OTHER

NCT05795842 - DELTA (Detecting and Predicting Atrial Fibrillation in Post-Stroke Patients) | Biotech Hunter | Biotech Hunter