Cardiac Arrythmias, Cardiac Event, Cardiac Implantable Electronic Device, Sleep Disorder
Conditions
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.
Interventions
DIAGNOSTIC_TESTDevice interrogation
All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.
Sponsors
Boston Scientific Corporation
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with atrial fibrillation | from enrollment to last follow-up (2 years) | cardiac implantable electronic device-detected or clinical atrial fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with complications associated with atrial fibrillation | from enrollment to last follow-up (2 years) | thromboembolic events, heart failure, ablation therapy for atrial fibrillation |
| Number of participants with ventricular arrhythmia | from enrollment to last follow-up (2 years) | cardiac implantable electronic device-detected or clinical ventricular arrhythmia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with major adverse composite events | from enrollment to last follow-up (2 years) | cardiac death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure |
Countries
South Korea
Outcome results
None listed