Conventional Lead Opposed to Novel ECG (CLONE)

NCT07624435 | Active Not Recruiting

• 1 other identifier: CLONE Version 1.0
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

ECG Monitoring

Keywords

Heart Signals; ECG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional 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.

Other Outcomes (2)

• 12 Lead ECG and Kardia signal duration analysis from 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.

  Adverse events will be collected and assessed from all data collection visits immediately following every data collection visit. All adverse events will be followed until resolved or for up to 30 days after the event.

Study Arms (1)

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

Interventions

ECG signals collection DEVICE

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

Also known as: Standard 12 lead ECG, Kardia ECG, Heartwatch ECG

Healthy volunteers

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HelpWear Inc.: lead

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 3, 2026
• Study Start: February 18, 2026
• Primary Completion: March 24, 2026
• Study Completion: August 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)