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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-28

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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

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Sleep Disorder Cardiac Arrythmias Cardiac Event Cardiac Implantable Electronic Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with low burden of sleep-disordered breathing

Device interrogation

Intervention Type DIAGNOSTIC_TEST

All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.

Patients with high burden of sleep-disordered breathing

Device interrogation

Intervention Type DIAGNOSTIC_TEST

All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.

Interventions

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Device interrogation

All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Berlin Questionnaire EuroQol five dimensions questionnaire

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No