Home Monitor for AA Burden Detection IIT in TWN (FF108)
The Clinical Follow-Up of the Amvia Pacemaker Family Using Atrial Anti-Tachycardia Pacing (aATP) and Home Monitoring Function in the Patients With Paroxysmal Atrial Fibrillation (PAF)
Primary Endpoint:
- Early detection rate in Atrial Arrhythmia (AA) burden
- Data transmission success rate for overall number of atrial burden collection during the monitoring period
Secondary Endpoints:
- Atrial burden occurrence at 3/6/12 months post-aATP
- Incidence of arrhythmia
- Safety: Immediate (< 24 hours), in-hospital, 3 months, 6 months and 12 months adverse events
Descripción general del estudio
Estado
Descripción detallada
This prospective observational single-arm, open-label, non-randomized, multi-center study to evaluate the impact of advanced remote monitoring technologies and features, such as the aATP function of BIOTRONIK pacemakers, in conjunction with wireless monitoring via the CardioMessenger 4G or its successors. The study population will consist of patients diagnosed with PAF or atrial flutter who will be/have been implanted with permanent pacemaker devices and CardioMessenger Smart Home Monitoring before joining the study.
Eligible patients will be enrolled through the process of informed consent in the clinical investigational sites across Taiwan with competitive enrollment.
All subjects enrolled in the study will use aATP and HM function of BIOTRONIK pacemakers. During the screen period, the subject's medical history and demographic information will be collected. The baseline data will be obtained prior to the pacing implantation. Depending on the needs of the subject, the screen and implantation procedures may be performed on the same day (within 12 weeks of baseline). Implant data will include features of aATP function, implant technique, and lead positioning. After completion of pacemaker implantation, subjects will be followed at 3, 6, and 12 months or until patient withdrawal or death. During follow-up, a determination/evaluation will be performed based on the data collection from the device system. Unscheduled visit will be arranged after investigator evaluated patient's data via HMSC and judged the clinic visit is needed.
With BIOTRONIK Home Monitoring, medical and technical data is sent from the implanted device to the CardioMessenger. This data is then forwarded to the BIOTRONIK Home Monitoring Service Center via the cellular telephone network.
Investigators who monitor subjects implanted device can review this data from the Home Monitoring Service Center website (HMSC website).
In the study, subject demographics (age, gender, height, weight, etc.) and comorbidities will be collected during the screen period. Implant procedure details and pacing parameters will be recorded. Both primary and secondary endpoints will be collected and evaluated at baseline and follow-up periods.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chih-Chieh Yu, MD.PhD
- Número de teléfono: 0972652038
- Correo electrónico: sweetchieh@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: HSIAO-HAN HUANG
- Número de teléfono: 0932917553
- Correo electrónico: clrhuang8853@gmail.com
Ubicaciones de estudio
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Taipei, Taiwán, 100
- National Taiwan University Hospita
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult patients ≥ 20 years of age
- Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device
- The diagnosis of AF is confirmed on a 12-lead electrocardiogram (ECG) or lasting >30 seconds in single lead ECG monitor
- Implanted within 12 weeks prior to enrollment or being considered for implantation of a PPM with Home Monitoring technology
- Able to give informed consent for the participation in the trial
Exclusion Criteria:
- Patients are not able to use CardioMessenger 4G or its successors
- Life expectancy < 1 year
- Sepsis
- Long-standing Persistent Atrial Fibrillation or Permanent Atrial Fibrillation
- Pregnant or breast-feeding women
- Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
- Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of Atrial Arrhythmia
- Present or history of drug addiction
- Any other condition that, in the investigator's judgment, might increase the risk to the patients or affect trial quality
- Patients underwent implantable cardioverter-defibrillator implantation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter
W who have been implanted or planned to implant with permanent pacemaker device
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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AA burden
Periodo de tiempo: From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
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From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of arrhythmia
Periodo de tiempo: From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
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From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202602039DIPC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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