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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring.
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))
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote monitoring | Device | CIED monitoiring with remote monitoring device |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes Biotronic CIED implanted patients in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea. Study population are included if they are more than 20year old, followed up at outpatient clinic > 6 months after CIED implantation, and are literate and have perceptibility on questionnaire.
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| Name | Affiliation | Role |
|---|---|---|
| YouMi Hwang, MD, PhD | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Suwon | Kyonggi Do | 16247 | South Korea |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |