An interventional study of Amiigo Watch Only and Amiigo Watch + BodyGuardian in Atrial Fibrillation, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
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).
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.
Exclusion Criteria:
Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.
Device: Amiigo Watch Only · Device: Amiigo Watch + BodyGuardian
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.
Also known as: Cardioversion
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.
Also known as: Cardioversion plus 30 days
Watch Accuracy during Cardioversion
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
Time frame: Duration of cardioversion procedure
Watch Accuracy compared to BodyGuardian
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.
Time frame: 30 days
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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