Remote Care for CIED Patients in Korea

NCT ID: NCT04557111

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

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))

Conditions

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Arrhythmias, Cardiac

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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remote monitoring

CIED monitoiring with remote monitoring device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role collaborator

Saint Vincent's Hospital, Korea

OTHER

Sponsor Role lead

Responsible Party

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You Mi Hwang

Assistant Professor in Internal Medicine, Cardiology, Cardiac Electrophysiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YouMi Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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St. Vincent's Hospital

Suwon, Kyonggi Do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Remote Care Study

Identifier Type: -

Identifier Source: org_study_id

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