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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03441022
• Other study ID #: 17-006346
• Secondary ID: 1R43AG058516-01
• Status: Withdrawn
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: August 2021

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Amiigo 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.
• Amiigo 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Koronis Biomedical Technologies, National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of cardioversion procedure
Primary	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.	30 days

External Links

•   Mayo Clinic Clinical Trials