Conventional Lead Opposed to Novel ECG (CLONE) (CLONE)

Conventional Lead Opposed to Novel ECG

To blindly assess, beat-by-beat, standard ECG intervals (QRS intervals, PQ intervals, and P wave durations) of paired standard lead v4 with paired HeartWatch signals over 20 to 30 seconds of noise-free data.

Study Overview

• Status: Active, not recruiting
• Conditions: ECG Monitoring
• Intervention / Treatment: Device: ECG signals collection

Detailed Description

This proof-of-concept study will enroll volunteers undergoing serial conventional 12-lead ECG rhythm strips who agree to wear a HeartWatch and use a Kardia mobile during those recordings.

The HeartWatch data will not be used for clinical decision-making. Rhythm strips from conventional 12-lead ECG recordings and the HeartWatch recordings will be obtained in volunteers in supine and standing positions and with the device placed in the recommended and in non-recommended positions (i.e., internally and externally rotated in keeping with the observed malposition identified in human factors testing environments (one inch or 2.5 cm; HelpWear, data on file).

Rhythm strips from serial 10-sec, 12-lead recordings will be obtained to allow for beat-by-beat comparisons of ECG intervals over the 20 to 30 seconds of noise free data. Specifically, the intervals from continuous v4 beats with paired continuous HeartWatch beats and the intervals from continuous lead I beats with paired continuous Kardia beats.

Since the HeartWatch is not intended to be used for evaluation of the ST segment or the QT interval, the comparison of the HeartWatch to standard lead v4 will exclude QT assessment.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording.

Description

Inclusion Criteria:

• At least 22 years of age at time of the conventional ECG recording
• Willing to participate in the study
• Able to follow the protocol

Exclusion Criteria

• Known allergy to the electrodes used for a conventional ECG
• Known allergy to any component of the HeartWatch
• Known allergy to any component of the Kardia system
• Inability to wear the HeartWatch on the left arm due to pre-existing medical condition (e.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot or recurrent blood clots in left arm, chronic neuropathic pain in left arm, …)
• Dextrocardia
• Implanted functional Pacemaker of Defibrillator
• Left upper arm circumference < 22 cm or > 45 cm

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy volunteers; Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording.

Device: ECG signals collection; A Health-Canada and FDA-approved 12-lead ECG system (GE Healthcare, MAC 5500 or equivalent) will be used to collect the 10-sec digital rhythm strips in the noted supine and standing positions. A total of twenty-four (24) recordings, four from each of position, will be collected from each consenting participant: Supine with HeartWatch in the recommended position; Standing with HeartWatch in the recommended position; Supine with HeartWatch in a one inch (2.5 cm) externally rotated position; Supine with HeartWatch in a one inch (2.5 cm) internally rotated position; Supine while collecting a 30-sec Kardia recording; Standing while collecting a 30-sec Kardia recording; Other Names: Standard 12 lead ECG; Kardia ECG; Heartwatch ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard ECG and HeartWatch interval duration assessment in standard position	The three co-primary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a supine position with the HeartWatch in the standard location.	The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions.	Secondary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a: standing position with the HeartWatch in the standard location;; supine position with the HeartWatch in a one inch (2.5 cm) externally rotated;; supine position with the HeartWatch in a one inch (2.5 cm) internally rotated.	The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 Lead ECG and Kardia signal duration analysis from supine and standing positions	Exploratory endpoints for this study, for comparative purposes, are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (Kardia system vs. lead I of a standard 12-lead ECG) in supine and standing positions.	The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
Device related adverse events.	The safety endpoint for this study is the incidence of device-related adverse events.	Adverse events will be collected and assessed from all data collection visits immediately following every data collection visit.

Collaborators and Investigators

• Sponsor: HelpWear Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Actual): March 24, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ECG; Heart Signals
• Other Study ID Numbers: CLONE Version 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This information will be used to validate a company's Intellectual property

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No