Prospective Multicenter Observation Study on the Association Between the Severity of Device-detected Sleep-disordered Breathing and the Risk of Cardiac Arrhythmic Events
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 600
- Locations
- 14
- Primary Endpoint
- Number of participants with atrial fibrillation
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of participants with atrial fibrillation
Time Frame: from enrollment to last follow-up (2 years)
cardiac implantable electronic device-detected or clinical atrial fibrillation
Secondary Outcomes
- Number of participants with ventricular arrhythmia(from enrollment to last follow-up (2 years))
- Number of participants with complications associated with atrial fibrillation(from enrollment to last follow-up (2 years))