Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (MICRA)
9. oktober 2017 oppdatert av: 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).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital
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Atlanta, Georgia, Forente stater, 30308
- Emory University Hospital Midtown
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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).
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).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
|
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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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
|
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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.
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Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2016
Primær fullføring (Faktiske)
24. oktober 2016
Studiet fullført (Faktiske)
24. oktober 2016
Datoer for studieregistrering
Først innsendt
19. april 2016
Først innsendt som oppfylte QC-kriteriene
29. april 2016
Først lagt ut (Anslag)
2. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00084576
Plan for individuelle deltakerdata (IPD)
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NEI
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