Arrhythmias, CardiacNCT04557111
Remote Care for CIED Patients in Korea
An observational study of Arrhythmias, Cardiac, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring. Read more about this study
- Who is it for?
- Ages 20 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- remote monitoring
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients with < 2 outpatient clinic visits during >6 months
- Illiterate patients or inapprehensive of questionnaire
- Patients with life expectancy of <1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality and Satisfaction in CIED Remote Monitoring
This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring.
Read the 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))
- Conditions
- Arrhythmias, Cardiac
- Being tested
- remote monitoring
- Keywords
- pacemaker, Implantable Cardioverter Defbrillator, Cardiac resynchronization therapy
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote monitoringDevice
CIED monitoiring with remote monitoring device
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Any changes in prescription or patient visit schedule
Any changes in prescription or patient visit schedule based on remote monitoring
Measured: 1 year
Out patient clinic time consumption per patient
Out patient clinic time consumption per patient
Measured: 1 year
Changes in CIED parameters
Changes in CIED parameters during remote monitoring
Measured: 1 year
Any cardiocerebrovascular events, deaths
Any cardiocerebrovascular events, deaths
Measured: 1 year
Admission for heart failure or any cardiovascular intervention
Admission for heart failure or any cardiovascular intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Principal investigator, You Mi Hwang, Saint Vincent's Hospital, Korea
- Investigators
- YouMi Hwang, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557111
- Sponsor's protocol ID
- Remote Care Study
- Status last verified
- Jul 2023
- First submitted
- 14 Sep 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality and Satisfaction in CIED Remote Monitoring
- ClinicalTrials.gov ID
- NCT04557111
- Acronym / sponsor ID
- Remote Care Study
- Conditions
- Arrhythmias, Cardiac
- Keywords
- pacemaker, Implantable Cardioverter Defbrillator, Cardiac resynchronization therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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))
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with < 2 outpatient clinic visits during >6 months
- Illiterate patients or inapprehensive of questionnaire
- Patients with life expectancy of <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote monitoringCIED monitoiring with remote monitoring device | Device | – |
Primary outcome
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
5 secondary outcomes
Any changes in prescription or patient visit schedule
Time frame: 1 year
Out patient clinic time consumption per patient
Time frame: 1 year
Changes in CIED parameters
Time frame: 1 year
Any cardiocerebrovascular events, deaths
Time frame: 1 year
Admission for heart failure or any cardiovascular intervention
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YouMi Hwang, MD, PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction measurement before and after remote monitoring (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.