Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (MICRA)
9 oktober 2017 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
20
Fase
- Niet toepasbaar
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
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Hospital
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Atlanta, Georgia, Verenigde Staten, 30308
- Emory University Hospital Midtown
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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
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
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
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Tijdsspanne: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
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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.
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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 Experiencing Asynchronous Pacing While Using a Tablet
Tijdsspanne: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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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.
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Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
Tijdsspanne: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
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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
Tijdsspanne: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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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.
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Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Tijdsspanne: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
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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
Tijdsspanne: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
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
1 april 2016
Primaire voltooiing (Werkelijk)
24 oktober 2016
Studie voltooiing (Werkelijk)
24 oktober 2016
Studieregistratiedata
Eerst ingediend
19 april 2016
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2016
Eerst geplaatst (Schatting)
2 mei 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 november 2017
Laatste update ingediend die voldeed aan QC-criteria
9 oktober 2017
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00084576
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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