DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Multicenter Observation Study on the Association Between the Severity of Device-detected Sleep-disordered Breathing and the Risk of Cardiac Arrhythmic Events

Conditions
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Sleep Disorder, Cardiac Arrythmias, Cardiac Event, Cardiac Implantable Electronic Device

Intervention / Treatment
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* Diagnostic Test: Device interrogation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 19years CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with low burden of sleep-disordered breathing<br> | Diagnostic Test: Device interrogation<br>* All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.<br>* Other names: EuroQol five dimensions questionnaire;|
| Patients with high burden of sleep-disordered breathing<br> | Diagnostic Test: Device interrogation<br>* All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.<br>* Other names: EuroQol five dimensions questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | cardiac implantable electronic device-detected or clinical ventricular arrhythmia | from enrollment to last follow-up (2 years) |