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

14 september 2026 bijgewerkt door: HelpWear Inc.

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

40

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Apparaat: 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
Andere namen:
  • Standard 12 lead ECG
  • Kardia ECG
  • Heartwatch ECG

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Standard ECG and HeartWatch interval duration assessment in standard position
Tijdsspanne: 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.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions.
Tijdsspanne: 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.

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:

  1. standing position with the HeartWatch in the standard location;
  2. supine position with the HeartWatch in a one inch (2.5 cm) externally rotated;
  3. 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
12 Lead ECG and Kardia signal duration analysis from supine and standing positions
Tijdsspanne: 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.
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.
Tijdsspanne: 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.
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. All adverse events will be followed until resolved or for up to 30 days after the event.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

HelpWear Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 februari 2026

Primaire voltooiing (Werkelijk)

24 maart 2026

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • CLONE Version 1.0

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

This information will be used to validate a company's Intellectual property

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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