An observational study in Sleep Disorder, Cardiac Arrythmias and Cardiac Event, sponsored by Samsung Medical Center. Status unknown at 15 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Samsung Medical Center · Observational
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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 600 is above the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Diagnostic Test: Device interrogation
Diagnostic Test: Device interrogation
All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.
Also known as: Berlin Questionnaire, EuroQol five dimensions questionnaire
Number of participants with atrial fibrillation
cardiac implantable electronic device-detected or clinical atrial fibrillation
Time frame: from enrollment to last follow-up (2 years)
Number of participants with complications associated with atrial fibrillation
thromboembolic events, heart failure, ablation therapy for atrial fibrillation
Time frame: from enrollment to last follow-up (2 years)
Number of participants with ventricular arrhythmia
cardiac implantable electronic device-detected or clinical ventricular arrhythmia
Time frame: from enrollment to last follow-up (2 years)
Number of participants with major adverse composite events
cardiac death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure
Time frame: from enrollment to last follow-up (2 years)
Plan to share: Undecided
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center