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SmartWatch ECG Evaluation Trial I

NCT05942274 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Stavros Stavrakis, MD · University of Oklahoma

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-03-31
Completion
2024-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05942274 on ClinicalTrials.gov