SmartWatch ECG Evaluation Trial I

May 20, 2024 updated by: University of Oklahoma
This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

  1. Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.
  2. Compare the ECG waveforms from the Smartwatch to the GE and KardiaMobile devices to demonstrate equivalence in terms of cross correlation (correlation coefficient >.95) and RMS Difference (<10 microvolts).
  3. Compare the algorithmic determination from the Smartwatch ECG to those of the GE and KardiaMobile to demonstrate equivalence.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female > 18 years of age.
  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
  • Being seen in the OU Cardiac Electrophysiology Outpatient Clinic.

Exclusion Criteria:

  • Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
  • Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screen group
This is a single-center, non-randomized open study with a single-patient clinical trial design (i.e., the patients serve as their own control).
Diagnostic test: We propose to validate these smartwatch ECG functions to support FDA submissions
1) Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QRS amplitude
Time Frame: 30 seconds
Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Stavros Stavrakis, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Actual)

April 18, 2024

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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