Atrial Fibrillation
Conditions
Keywords
Cardioversion, BodyGuardian, Amiigo Wristband
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.
Interventions
DEVICEAmiigo Watch Only
Subjects will be asked to wear a wrist band with capabilities to detect their heart rate or rhythm on the basis of PPG on either wrist around the time of their cardioversion procedure. Data will be acquired from the wrist band at the same time as the electrocardiogram (ECG) monitor to which subjects are hooked up for the purposes of the cardioversion.
DEVICEAmiigo Watch + BodyGuardian
Subjects will be sent home after the cardioversion with a 30 day heart monitor called the BodyGuardian. This device continuously monitors their heart rate and rhythm and they will wear this on the chest. Subjects will also wear the wrist monitor over the same 30 day period.
Sponsors
Koronis Biomedical Technologies
National Institute on Aging (NIA)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation 2. Willing and able to provide informed consent and follow the study protocol 3. Clinically indicated planned restoration of normal rhythm
Exclusion criteria
1. Unable to provide informed consent 2. Unable to follow the study protocol 3. Women who are pregnant 4. Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Watch Accuracy during Cardioversion | 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 |
| Watch Accuracy compared to BodyGuardian | 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. |
Outcome results
None listed