Arrhythmias, Cardiac
Conditions
Keywords
pacemaker, Implantable Cardioverter Defbrillator, Cardiac resynchronization therapy
Brief summary
This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring.
Detailed description
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))
Interventions
DEVICEremote monitoring
CIED monitoiring with remote monitoring device
Sponsors
Biotronik SE & Co. KG
Saint Vincent's Hospital, Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with Biotronic CIED implanted in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea 2. Patients who are literate and have perceptibility on questionnaire 3. Patients who followed up more than 6 months after CIED implantation 4. Patients with age of \>20 years
Exclusion criteria
1. Patients with \< 2 outpatient clinic visits during \>6 months 2. Illiterate patients or inapprehensive of questionnaire 3. Patients with life expectancy of \<1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction measurement before and after remote monitoring | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any changes in prescription or patient visit schedule | 1 year | Any changes in prescription or patient visit schedule based on remote monitoring |
| Out patient clinic time consumption per patient | 1 year | Out patient clinic time consumption per patient |
| Changes in CIED parameters | 1 year | Changes in CIED parameters during remote monitoring |
| Any cardiocerebrovascular events, deaths | 1 year | Any cardiocerebrovascular events, deaths |
| Admission for heart failure or any cardiovascular intervention | 1 year | Admission for heart failure or any cardiovascular intervention |
Countries
South Korea
Outcome results
None listed