SmartWatch ECG Evaluation Trial I

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: We propose to validate these smartwatch ECG functions to support FDA submissions

• Registration Number: NCT05942274
• Lead Sponsor: University of Oklahoma

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 Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-12
• Study Start: 2023-12
• Primary Completion: 2024-03
• Study Completion: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screen group	We propose to validate these smartwatch ECG functions to support FDA submissions	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).

Primary Outcome Measures

Name	Time	Method
QRS amplitude	30 seconds	Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States