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

Samsung Medical Center600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Sleep Disorder Cardiac Arrythmias Cardiac Event Cardiac Implantable Electronic Device

Interventions

Device interrogationDIAGNOSTIC_TEST

All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (15)

Samsung Changwon Medical Center

Changwon, South Korea

Chungbuk National University Hospital

Chungju, South Korea

Chonnam National University Hospital

Daegu, South Korea

Outcomes

Primary Outcomes

Number of participants with atrial fibrillation

cardiac implantable electronic device-detected or clinical atrial fibrillation

Time frame: from enrollment to last follow-up (2 years)

Secondary Outcomes

Number of participants with complications associated with atrial fibrillation

thromboembolic events, heart failure, ablation therapy for atrial fibrillation

Time frame: from enrollment to last follow-up (2 years)

Number of participants with ventricular arrhythmia

cardiac implantable electronic device-detected or clinical ventricular arrhythmia

Time frame: from enrollment to last follow-up (2 years)

Data from ClinicalTrials.gov

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