Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (MICRA)
9 de octubre de 2017 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2016
Finalización primaria (Actual)
24 de octubre de 2016
Finalización del estudio (Actual)
24 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
19 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2016
Publicado por primera vez (Estimar)
2 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de noviembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
9 de octubre de 2017
Última verificación
1 de octubre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00084576
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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