Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (MICRA)
9 oktober 2017 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown
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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Tidsram: 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.
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Tidsram: 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
Tidsram: 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)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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
1 april 2016
Primärt slutförande (Faktisk)
24 oktober 2016
Avslutad studie (Faktisk)
24 oktober 2016
Studieregistreringsdatum
Först inskickad
19 april 2016
Först inskickad som uppfyllde QC-kriterierna
29 april 2016
Första postat (Uppskatta)
2 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00084576
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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