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Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor

6 juni 2022 uppdaterad av: PulseOn Oy
The study investigates the performance pf PulseOn Arrhythmia Monitor System that includes a wrist-worn device, which combines continuous optical heartbeat interval monitoring and intermittent ECG measurement, and a data management system used by healthcare professionals for data observation, in the detection of previously undiagnosed cardiac arrhythmias, especially atrial fibrillation.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The study consists of monitoring voluntary subjects with PulseOn Arrhythmia Monitoring System for the period of two weeks. The subjects are recruited mainly through newspaper advertisements. The study is executed in Tampere and Helsinki areas, Finland.

During the two week monitoring time, the subjects are instructed to wear the wrist device continuously, except when taking the device off e.g. for going to sauna or swimming, and for charging. The subjects are instructed to perform a 35-second ECG measurement (recording) in three cases:

  1. Scheduled recording four times a day
  2. In case of suspecting arrhythmic event, i.e. feeling symptoms
  3. In case the wrist device instructs to perform a recording by vibrating and showing an LED light

The data collected in the study is analysed post-hoc. In the post-hoc analysis, the cardiac rhythm assessed automatically from the ECG measurements is visually confirmed by a cardiologist.

Studietyp

Interventionell

Inskrivning (Förväntat)

200

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

Studieorter

  • Finland
      • Tampere, Finland
        • Rekrytering
        • Tampere Heart Hospital
        • Kontakt:
          • Research coordinator at Heart Hospital
          • Telefonnummer: +358417306125

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

50 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria for the main study group:

  • At least 65 years of age
  • Self-assessed ability to use the study devices
  • Ability to give informed consent
  • Volunteering for the study

Inclusion criteria for the active endurance athlete group:

  • Minimum of 10 years of active training of endurance sport (e.g. long distance running, skiing, cycling, triathlon…) and currently an average amount of training of at least 10 hours a week.
  • Age: ≥ 50 years
  • Self-assessed ability to use the study devices
  • Ability to give informed consent
  • Volunteering for the study

Exclusion Criteria for both groups:

  • Cardiac pacemaker
  • Earlier diagnosis of atrial fibrillation
  • Inability to give informed consent
  • Denial

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Main study group
Normal subjects of at least 65 years of age
Enhet: PulseOn Arrhythmia Monitor device
Wearing of the wrist device for a period of two weeks
Experimentell: Endurance athlete group
Group consists of active endurance athletes of at least 50 years of age
Enhet: PulseOn Arrhythmia Monitor device
Wearing of the wrist device for a period of two weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnostic performance improvement with continuous optical measurement
Tidsram: Duration of patient measurement, i.e. two weeks
Percentual improvement in the performance of detecting previously undiagnosed atrial fibrillation in the study population by the continuous PPG-based heartbeat interval monitoring when compared with relying only on scheduled and symptom -based ECG measurements. Cardiac rhythm assessed by a cardiologist from the ECG measurements that are made as a result of PPG-based arrhythmia notifications is compared with rhythm assessments made only from the scheduled and symptom-based ECG measurements. It is evaluated whether more subjects can be diagnosed having atrial fibrillation with the help of continuous PPG-based rhythm monitoring.
Duration of patient measurement, i.e. two weeks
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.
Tidsram: Duration of patient measurement, i.e. two weeks
Data recorded by the study subjects during the two-week study time is assessed by a cardiologist and subjects are classified as having: "no observed arrhythmias", "atrial fibrillation episode(s)", "other potential arrhythmia", or "unconfident assessment" (due to the quality or lack of data). The percentage of "unconfident assessment" shall be less than 20% of the subjects.
Duration of patient measurement, i.e. two weeks
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
Tidsram: Duration of patient measurement, i.e. two weeks
The feedback from the subjects should show at least grade 3 in a scale of 1-5 for the "comfortability of using the wrist device".
Duration of patient measurement, i.e. two weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.
Tidsram: Duration of patient measurement, i.e. two weeks
The visual ECG-based rhythm annotation made by a cardiologist is compared with simultaneous PPG-algorithm alarm state. The incidence of notifications for other arrhythmias than atrial fibrilation is reported.
Duration of patient measurement, i.e. two weeks
Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.
Tidsram: Duration of patient measurement, i.e. two weeks
Evaluation is done by comparing the atrial fibrillation detection outcome when considering only the PPG-triggered and symptom-based ECG measurements or when considering also the scheduled ECG measurements. The outcome parameter is the number of subjects that would have been left undetected if the scheduled ECG measurements were not taken.
Duration of patient measurement, i.e. two weeks
Feedback about the usability of the evaluated solution from study subjects.
Tidsram: At the end of the 2-week measurement period
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the wrist device, understandability of the user interface, suitability of the user materials, and unobtrusiveness.
At the end of the 2-week measurement period
Feedback about the usability of the evaluated solution from study personnel.
Tidsram: At the end of the study i.e. the end of 2022.
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the data management service, suitability of the user materials.
At the end of the study i.e. the end of 2022.
Quality of the measured ECG signals
Tidsram: Duration of patient measurement, i.e. two weeks
Percentage of the ECG measurements classified as inadequate quality for rhythm assessment either an ECG analysis algorithm or by a doctor.
Duration of patient measurement, i.e. two weeks
Assessment of the subjects' adherence in using the solution.
Tidsram: Duration of patient measurement, i.e. two weeks
Analysis of how well the participants will follow the study protocol and do the participants register their ECG in correlation with the wrist device notification. The outcome parameter is the percentage of scheduled and PPG-based notifications to take an ECG measurement and the variation of the percentage between the subjects.
Duration of patient measurement, i.e. two weeks
Benefit of optical measurement for the speed of detecting atrial fibrillation
Tidsram: Duration of patient measurement, i.e. two weeks
Comparison of the time to the first detection of atrial fibrillation or other arrhythmia when considering PPG-triggered ECG measurements or when considering the scheduled ECG measurements.
Duration of patient measurement, i.e. two weeks
Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.
Tidsram: Duration of patient measurement, i.e. two weeks
The automated assessment done for the 30-second ECG recordings is compared with the visual assessment to calculate the sensitivity and specificity for each rhythm category.
Duration of patient measurement, i.e. two weeks

Samarbetspartners och utredare

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

Sponsor

PulseOn Oy

Samarbetspartners

TAYS Sydänkeskus Oy
Atostek Oy

Utredare

  • Huvudutredare: Vesa Virtanen, PhD (med), Heart Hospital of Tampere University Hospital

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)

22 maj 2022

Primärt slutförande (Förväntat)

31 december 2022

Avslutad studie (Förväntat)

31 december 2022

Studieregistreringsdatum

Först inskickad

18 november 2021

Först inskickad som uppfyllde QC-kriterierna

18 januari 2022

Första postat (Faktisk)

19 januari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juni 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juni 2022

Senast verifierad

1 juni 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AinoScreening

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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