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

Samsung Medical Center logo

Samsung Medical Center

Status

Unknown

Conditions

Cardiac Arrythmias
Sleep Disorder
Cardiac Implantable Electronic Device
Cardiac Event

Treatments

Diagnostic Test: Device interrogation

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03614377
SMC 2017-03-017-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Patients with low burden of sleep-disordered breathing
Treatment:
Diagnostic Test: Device interrogation
Patients with high burden of sleep-disordered breathing
Treatment:
Diagnostic Test: Device interrogation

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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