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Clinical Trials/NCT05942274
NCT05942274WithdrawnNot Applicable

SmartWatch ECG Evaluation Trial I

University of Oklahoma2 sites in 1 countryStarted: December 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
QRS amplitude
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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