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

• Conditions: Cardiac Event; Sleep Disorder; Cardiac Arrythmias; Cardiac Implantable Electronic Device
• Interventions: Diagnostic Test: Device interrogation

• Registration Number: NCT03614377
• Lead Sponsor: Samsung Medical Center

Brief 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.

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 Timeline

• Study Start: 2017-04-28
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-06-30
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• age ≥ 19years
• CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with low burden of sleep-disordered breathing	Device interrogation	-
Patients with high burden of sleep-disordered breathing	Device interrogation	-

Primary Outcome Measures

Name	Time	Method
Number of participants with atrial fibrillation	from enrollment to last follow-up (2 years)	cardiac implantable electronic device-detected or clinical atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Number of participants with ventricular arrhythmia	from enrollment to last follow-up (2 years)	cardiac implantable electronic device-detected or clinical ventricular arrhythmia
Number of participants with complications associated with atrial fibrillation	from enrollment to last follow-up (2 years)	thromboembolic events, heart failure, ablation therapy for atrial fibrillation

Trial Locations

Locations (14)

Chungbuk National University Hospital; 🇰🇷 Chungju, Korea, Republic of

Samsung Changwon Medical Center; 🇰🇷 Changwon, Korea, Republic of

Yeongnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Sejong General Hospital; 🇰🇷 Sejong, Korea, Republic of

Eulji University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of