Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Mayo Clinic
- Primary Endpoint
- Watch Accuracy compared to BodyGuardian
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).
Detailed Description
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.
Investigators
Suraj Kapa
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
- •Willing and able to provide informed consent and follow the study protocol
- •Clinically indicated planned restoration of normal rhythm
Exclusion Criteria
- •Unable to provide informed consent
- •Unable to follow the study protocol
- •Women who are pregnant
- •Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
Outcomes
Primary Outcomes
Watch Accuracy compared to BodyGuardian
Time Frame: 30 days
Determine the accuracy of ambulatory photoplethysmography for detection of heart rhythm when compared with a wearable clinically available 30 day monitor (BodyGuardian) in terms of accuracy of AF detection.
Watch Accuracy during Cardioversion
Time Frame: Duration of cardioversion procedure
Determine whether the R-R interval estimate from artifact-free non-invasive photoplethysmography sample waveform segments is a reasonable basis for a atrial fibrillation (AF) detection algorithm as compared to a gold standard measurement from ECG in the acute cardioversion setting