SmartWatch ECG Evaluation Trial I

Atrial Fibrillation Clinical Trial

Official title:

SmartWatch ECG Evaluation Trial I

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05942274
• Other study ID #: 16143
• Status: Withdrawn
• Phase: N/A
• Start date: December 2023
• Est. completion date: April 18, 2024

Study information

• Verified date: May 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 18, 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QRS amplitude	Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.	30 seconds