NCT03614377

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorder
• Cardiac Arrythmias
• Cardiac Event
• Cardiac Implantable Electronic Device

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Device interrogation	All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.

Timeline

• Start date: 2017-04-28
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2018-08-03
• Last updated: 2021-06-30

Locations

15 sites across 1 country: South Korea