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Clinical Trials/NCT03614377
NCT03614377UnknownNot Applicable

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

Samsung Medical Center14 sites in 1 country600 target enrollmentStarted: April 28, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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