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Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (MICRA)

9. oktober 2017 opdateret af: Mikhael El Chami, Emory University
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

With advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. There are magnets in smart phones and tablets that could affect the functions of pacemakers. The main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (MICRA device) implanted inside them. Participants will be asked to report any symptoms that they experience during the testing.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University Hospital Midtown

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
  • Able to consent

Exclusion Criteria:

  • Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
  • Children and vulnerable populations

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Participants with MICRA Device
Participants that received the MICRA device prior to study enrollment will have monitored use of Smart Phone and Tablet at one study visit. Electrogram printing will take place during use of each device to see if there is any pacing inhibition or asynchronous pacing.
Enhed: Use of a Tablet
Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using Tablet and while using the Tablet. The measured position of the Tablets tested will be normal routine position (noting at least 6 inches/15 centimeters from their pacemaker).
Enhed: Use of a Smart Phone
Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using a Smart phone and while using the Smart phone. The position of the Smart phone tested will be normal position at the ear and while texting (noting at least 6 inches/15 centimeters from their pacemaker).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Tidsramme: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
Tidsramme: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.
Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
Tidsramme: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Device Response While Using a Tablet, Assessed by Ventricular Pacing
Tidsramme: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.
Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Tidsramme: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Participants were asked to report any clinical symptoms that they experienced when using the smart phone.
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Number of Participants Reporting Clinical Symptoms While Using a Tablet
Tidsramme: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Participants were asked to report any clinical symptoms that they experienced when using the tablet.
Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2016

Primær færdiggørelse (Faktiske)

24. oktober 2016

Studieafslutning (Faktiske)

24. oktober 2016

Datoer for studieregistrering

Først indsendt

19. april 2016

Først indsendt, der opfyldte QC-kriterier

29. april 2016

Først opslået (Skøn)

2. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00084576

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Bradycardia, Atrial Tachyarrhythmia

Kliniske forsøg med Use of a Tablet

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner