Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Device: Amiigo Watch Only; Device: Amiigo Watch + BodyGuardian

• Registration Number: NCT03441022
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Study Start: 2021-07-15
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardioversion	Amiigo Watch + BodyGuardian	Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.
Cardioversion	Amiigo Watch Only	Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.

Primary Outcome Measures

Name	Time	Method
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.
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