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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with low burden of sleep-disordered breathing |
| ||
| Patients with high burden of sleep-disordered breathing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device interrogation | Diagnostic Test | All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with atrial fibrillation | cardiac implantable electronic device-detected or clinical atrial fibrillation | from enrollment to last follow-up (2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complications associated with atrial fibrillation | thromboembolic events, heart failure, ablation therapy for atrial fibrillation | from enrollment to last follow-up (2 years) |
| Number of participants with ventricular arrhythmia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with major adverse composite events | cardiac death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure | from enrollment to last follow-up (2 years) |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Changwon Medical Center | Changwon | South Korea | ||||
| Chungbuk National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30665804 | Derived | 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. |
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|
cardiac implantable electronic device-detected or clinical ventricular arrhythmia |
| from enrollment to last follow-up (2 years) |
| Chungju |
| South Korea |
| Chonnam National University Hospital | Daegu | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Yeongnam University Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Eulji University Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Sejong General Hospital | Sejong | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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