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

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

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

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

Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following 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