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

Sleep Disorder Clinical Trial

— DEDiCATES  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03614377
• Other study ID #: SMC 2017-03-017-010
• Status: Active, not recruiting
• Start date: April 28, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: June 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrythmias
• Cardiac Event
• Cardiac Implantable Electronic Device
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Device interrogation
All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Changwon Medical Center	Changwon
Korea, Republic of	Chungbuk National University Hospital	Chungju
Korea, Republic of	Chonnam National University Hospital	Daegu
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Yeongnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Sejong General Hospital	Sejong
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

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Boston Scientific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Number of participants with atrial fibrillation	cardiac implantable electronic device-detected or clinical atrial fibrillation	from enrollment to last follow-up (2 years)
Secondary	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)
Secondary	Number of participants with ventricular arrhythmia	cardiac implantable electronic device-detected or clinical ventricular arrhythmia	from enrollment to last follow-up (2 years)