Sleep DisorderDEDiCATESNCT03614377
DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)
An observational study of Sleep Disorder and Cardiac Arrythmias, run by Samsung Medical Center at 15 sites in South Korea.
Trial summary
This prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sleep Disorder, Cardiac Arrythmias, Cardiac Event
- What is being tested?
- Device interrogation
- How many people
- 600 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 28 Apr 2017to 31 Jul 2022
- How long will I take part?
- 2 Years
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent implantation of cardiac implantable electronic device (CIED) with AP scan function (Boston Scientific.Inc) are eligible for the study during the first 3±1 months after CIED implantation.
Who may be able to join
- age ≥ 19years
- CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female
Who cannot join
- CIED without atrial lead
- persistent or permanent atrial fibrillation (AF) or flutter
- history of catheter of surgical ablation of AF
- valvular steno-insufficiency more than moderate degree
- chronic obstructive pulmonary disease
- under current treatment for sleep-disordered breathing
- life expectancy < 1year
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Samsung Changwon Medical Center
Changwon
Chungbuk National University Hospital
Chungju
Chonnam National University Hospital
Daegu
Daegu Catholic University Medical Center
Daegu
Yeongnam University Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Eulji University Hospital
Daejeon
Chonnam National University Hospital
Gwangju
Sejong General Hospital
Sejong
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Prospective Multicenter Observation Study on the Association Between the Severity of Device-detected Sleep-disordered Breathing and the Risk of Cardiac Arrhythmic Events
This prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes.
Read the detailed description
The prevalence of SDB high in patients with cardiac implantable electronic device (CIED). Recently, device-detected SDB events showed a correlation with sleep-disordered breathing (SDB) diagnosed by polysomnography. Thus, CIED will facilitate early detection and monitoring of SDB in patients with CIEDs. Few studies investigated prognostic value of CIED-detected SDB in risk of cardiovascular events. Therefore, the primary aim is to determine whether device-detected SDB are associated with increased risk of cardiac arrhythmias or other cardiovascular morbidities using a prospective multicenter registry.
- Being tested
- Device interrogation
- Medical subject headings
- Sleep Wake Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device interrogationDiagnostic test
Also called Berlin Questionnaire, EuroQol five dimensions questionnaire
All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with low burden of sleep-disordered breathing | Not described Receives: Diagnostic Test: Device interrogation | |
| Patients with high burden of sleep-disordered breathing | Not described Receives: Diagnostic Test: Device interrogation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with atrial fibrillation
cardiac implantable electronic device-detected or clinical atrial fibrillation
Measured: from enrollment to last follow-up (2 years)
Secondary outcomes (2)
Number of participants with complications associated with atrial fibrillation
thromboembolic events, heart failure, ablation therapy for atrial fibrillation
Measured: from enrollment to last follow-up (2 years)
Number of participants with ventricular arrhythmia
cardiac implantable electronic device-detected or clinical ventricular arrhythmia
Measured: from enrollment to last follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start28 Apr 2017
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Seung-Jung Park, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614377
- Sponsor's protocol ID
- SMC 2017-03-017-010
- Acronym
- DEDiCATES
- Status last verified
- Jun 2021
- First submitted
- 30 Jul 2018
- Last updated
- 30 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gwag HB, Park Y, Lee SS, Kim JS, Park KM, On YK, Lee DI, Shin DG, Choi EK, Kang GH, Park HS, Park HW, Shim JM, Uhm JS, Kim J, Kim JH, Kang KW, Park SW, Oh YS, Cho Y, Lee YS, Park SJ. Rationale, design, and endpoints of the 'DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)' study: Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing. Int J Cardiol. 2019 Apr 1;280:69-73. doi: 10.1016/j.ijcard.2019.01.045. Epub 2019 Jan 15.
PubMed 30665804
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observation Study on the Association Between the Severity of Device-detected Sleep-disordered Breathing and the Risk of Cardiac Arrhythmic Events
- ClinicalTrials.gov ID
- NCT03614377
- Acronym / sponsor ID
- DEDiCATES / SMC 2017-03-017-010
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 3 Aug 2018 (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 prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes.
Detailed description
The prevalence of SDB high in patients with cardiac implantable electronic device (CIED). Recently, device-detected SDB events showed a correlation with sleep-disordered breathing (SDB) diagnosed by polysomnography. Thus, CIED will facilitate early detection and monitoring of SDB in patients with CIEDs. Few studies investigated prognostic value of CIED-detected SDB in risk of cardiovascular events. Therefore, the primary aim is to determine whether device-detected SDB are associated with increased risk of cardiac arrhythmias or other cardiovascular morbidities using a prospective multicenter registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with low burden of sleep-disordered breathing | – | Diagnostic Test: Device interrogation |
| Patients with high burden of sleep-disordered breathing | – | Diagnostic Test: Device interrogation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent implantation of cardiac implantable electronic device (CIED) with AP scan function (Boston Scientific.Inc) are eligible for the study during the first 3±1 months after CIED implantation.
Key inclusion criteria (2 listed)
- age ≥ 19years
- CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female
Key exclusion criteria (7 listed)
- CIED without atrial lead
- persistent or permanent atrial fibrillation (AF) or flutter
- history of catheter of surgical ablation of AF
- valvular steno-insufficiency more than moderate degree
- chronic obstructive pulmonary disease
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 |
|---|---|---|
| Device interrogationAlso: Berlin Questionnaire, EuroQol five dimensions questionnaireAll devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment. | Diagnostic test | Patients with high burden of sleep-disordered breathing, Patients with low burden of sleep-disordered breathing |
Primary outcome
Number of participants with atrial fibrillation
Time frame: from enrollment to last follow-up (2 years)
cardiac implantable electronic device-detected or clinical atrial fibrillation
2 secondary outcomes
Number of participants with complications associated with atrial fibrillation
Time frame: from enrollment to last follow-up (2 years)
Number of participants with ventricular arrhythmia
Time frame: from enrollment to last follow-up (2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Derived from this study: PubMed 30665804Gwag HB, Park Y, Lee SS, Kim JS, Park KM, On YK, Lee DI, Shin DG, Choi EK, Kang GH, Park HS, Park HW, Shim JM, Uhm JS, Kim J, Kim JH, Kang KW, Park SW, Oh YS, Cho Y, Lee YS, Park SJ. Rationale, design, and endpoints of the 'DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)' study: Prospective multicenter observational study of device-detected tachyarrhythmia and sleep-disordered breathing. Int J Cardiol. 2019 Apr 1;280:69-73. doi: 10.1016/j.ijcard.2019.01.045. Epub 2019 Jan 15.
- 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.
Seung-Jung Park, PhD principal investigator
Samsung Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Cardiac Arrythmias, run by Samsung Medical Center at 15 sites 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Results are not available in the source record.
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?
Number of participants with atrial fibrillation (time frame: from enrollment to last follow-up (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614377, which also lists 1 linked publication.
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 30 Jun 2021.