Conditions

ECG Monitoring

Keywords

Heart SignalsECG

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 collectionDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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

Sponsors & Collaborators

HelpWear Inc.
Industrylead

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Conventional Lead Opposed to Novel ECG (CLONE)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

Healthy volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

Healthy volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations