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
1 other identifier
observational
600
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2017
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedJune 30, 2021
June 1, 2021
5.3 years
July 30, 2018
June 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with atrial fibrillation
cardiac implantable electronic device-detected or clinical atrial fibrillation
from enrollment to last follow-up (2 years)
Secondary Outcomes (2)
Number of participants with complications associated with atrial fibrillation
from enrollment to last follow-up (2 years)
Number of participants with ventricular arrhythmia
from enrollment to last follow-up (2 years)
Other Outcomes (1)
Number of participants with major adverse composite events
from enrollment to last follow-up (2 years)
Study Arms (2)
Patients with low burden of sleep-disordered breathing
Patients with high burden of sleep-disordered breathing
Interventions
All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.
Eligibility Criteria
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.
You may qualify if:
- age ≥ 19years
- CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Boston Scientific Corporationcollaborator
Study Sites (15)
Samsung Changwon Medical Center
Changwon, South Korea
Chungbuk National University Hospital
Chungju, South Korea
Chonnam National University Hospital
Daegu, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Yeongnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Eulji University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Sejong General Hospital
Sejong, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 30665804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, PhD
Samsung Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
April 28, 2017
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
June 30, 2021
Record last verified: 2021-06