Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

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The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

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Detailed Description

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The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night

Conditions

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Bradycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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REPLY 200 implanted patients

Group Type EXPERIMENTAL

REPLY 200

Intervention Type DEVICE

REPLY 200 pacemaker

Interventions

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REPLY 200

REPLY 200 pacemaker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
* Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
* Patients who provide signed and dated informed consent

Exclusion Criteria

* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical study that could affect the results of this study
* Inability or refusal to provide informed consent
* Patient is minor (less than 18-years old)
* Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)
* Patient is forfeiture of freedom or under guardianship

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No