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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Disorder; Cardiac Event; Cardiac Arrythmias; Cardiac Implantable Electronic Device
• Intervention / Treatment: Diagnostic test: Device interrogation

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of
    • Samsung Changwon Medical Center
  • Chungju, Korea, Republic of
    • Chungbuk National University Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Chonnam National University Hospital
  • Daegu, Korea, Republic of
    • Yeongnam University Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of
    • Eulji University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Sejong, Korea, Republic of
    • Sejong General Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with low burden of sleep-disordered breathing	Diagnostic test: Device interrogation; All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.; Other Names: Berlin Questionnaire; EuroQol five dimensions questionnaire
Patients with high burden of sleep-disordered breathing	Diagnostic test: Device interrogation; All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.; Other Names: Berlin Questionnaire; EuroQol five dimensions questionnaire

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2017
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): July 31, 2022

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (ACTUAL): August 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Wake Disorders; Arrhythmias, Cardiac
• Other Study ID Numbers: SMC 2017-03-017-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No