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

14 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

40

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Enhet: 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
Andra namn:
  • Standard 12 lead ECG
  • Kardia ECG
  • Heartwatch ECG

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Standard ECG and HeartWatch interval duration assessment in standard position
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions.
Tidsram: 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.

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
12 Lead ECG and Kardia signal duration analysis from supine and standing positions
Tidsram: 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.
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

HelpWear Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 februari 2026

Primärt slutförande (Faktisk)

24 mars 2026

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

27 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • CLONE Version 1.0

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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