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

NCT03441022 | Withdrawn FDA Device

• 2 other identifiers: 17-0063461R43AG058516-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Atrial Fibrillation

Keywords

Cardioversion; BodyGuardian; Amiigo Wristband

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Cardioversion

EXPERIMENTAL

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

Interventions

Amiigo Watch Only DEVICE

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

Cardioversion

Amiigo Watch + BodyGuardian DEVICE

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

Cardioversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• Koronis Biomedical Technologies: collaborator
• National Institute on Aging (NIA): collaborator

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Suraj Kapa, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: July 15, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09