Clinical trial NCT03614377: DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disorder
Cardiac Arrythmias
Cardiac Event
Cardiac Implantable Electronic Device
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2018-08-03
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with atrial fibrillation
timeFrame: from enrollment to last follow-up (2 years)
Secondary outcomes:
measure: Number of participants with complications associated with atrial fibrillation
timeFrame: from enrollment to last follow-up (2 years)
measure: Number of participants with ventricular arrhythmia
timeFrame: from enrollment to last follow-up (2 years)
Other outcomes:
measure: Number of participants with major adverse composite events
timeFrame: from enrollment to last follow-up (2 years)
Locations:
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Medical Center
city: Chungju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Sejong
country: Korea, Republic of
facility: Sejong General Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Samsung Medical Center
name: Seung-Jung Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.