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OpenTrials
Completed

NCT Number: NCT04557111

Remote Care for CIED Patients in Korea

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

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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent's Hospital

Suwon, Kyonggi Do, 16247, South Korea

About this study

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))

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote monitoring

Device

CIED monitoiring with remote monitoring device

Primary outcomes

  1. Satisfaction measurement before and after remote monitoring

    Time frame: 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 outcomes

  1. Any changes in prescription or patient visit schedule

    Time frame: 1 year

    Any changes in prescription or patient visit schedule based on remote monitoring

  2. Out patient clinic time consumption per patient

    Time frame: 1 year

    Out patient clinic time consumption per patient

  3. Changes in CIED parameters

    Time frame: 1 year

    Changes in CIED parameters during remote monitoring

  4. Any cardiocerebrovascular events, deaths

    Time frame: 1 year

    Any cardiocerebrovascular events, deaths

  5. Admission for heart failure or any cardiovascular intervention

    Time frame: 1 year

    Admission for heart failure or any cardiovascular intervention

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study title

Quality and Satisfaction in CIED Remote Monitoring

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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