Remote Care for CIED Patients in Korea

Study Overview
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Brief Summary
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This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring.

Detailed Description
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Patient satisfaction (using questionnaire) before and after wireless/wired monitoring and outpatient treatment time, variables in heart transplantation devices for wireless/wired monitoring, presence of heart failure, cardiovascular events such as arrhythmia, myocardial infarction or cerebral infarction, thromboembolism and admission related to cardiovascular cause. The questionnaire was adopted and modified from modified Korean version of HoMASQ (by YouMi Hwang,2021 from HoMASQ; Europace (2010))

Official Title
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Quality and Satisfaction in CIED Remote Monitoring

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: remote monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Biotronic CIED implanted in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea Patients who are literate and have perceptibility on questionnaire Patients who followed up more than 6 months after CIED implantation Patients with age of >20 years Exclusion Criteria: Patients with < 2 outpatient clinic visits during >6 months Illiterate patients or inapprehensive of questionnaire Patients with life expectancy of <1 year

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: remote monitoring|CIED monitoiring with remote monitoring device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction measurement before and after remote monitoring | Satisfaction measurement by questionnaire: Survey on telehealth patient experience(modified Korean version by YouMi Hwang,2020 from Bas-Villalobos, Form I) and Post remote monitoring satisfaction questionnaire, modified Korean version by YouMi Hwang,2020 from HoMASQ (Home Monitoring Acceptance and Satisfaction Questionnaire, Form II): Usually higher scores mean a worse outcome | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any changes in prescription or patient visit schedule | Any changes in prescription or patient visit schedule based on remote monitoring | 1 year | 
| Out patient clinic time consumption per patient | Out patient clinic time consumption per patient | 1 year | 
| Changes in CIED parameters | Changes in CIED parameters during remote monitoring | 1 year | 
| Any cardiocerebrovascular events, deaths | Any cardiocerebrovascular events, deaths | 1 year | 
| Admission for heart failure or any cardiovascular intervention | Admission for heart failure or any cardiovascular intervention | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, Implantable Cardioverter Defbrillator, Cardiac resynchronization therapy