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

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

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

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

Conditions
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Bradycardia

Intervention / Treatment
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* Device: REPLY 200


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REPLY 200 implanted patients<br>REPLY 200 implanted patients | Device: REPLY 200<br>* REPLY 200 pacemaker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-based sensitivity of breathing troubles | Evaluation of this outcome requires measuring the number of ventilation pauses and ventilation reductions detected during the same night using SDB Monitoring function or the reference in-lab PSG (clinical assessment). | 1 day | 
| Event-based Positive Predictive Value of breathing troubles | The Event-based Positive Predictive Value (PPV)of breathing troubles is complementary to Sensitivity. It is the proportion of abnormal events appropriately detected by SDB Monitoring function compared to the total number of abnormal events detected by SDB Monitoring function. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Index-based Positive Predictive Value | The objective is to assess the Positive Prédictive Value of the SDB Monitoring function based on RDI stored in the pacemaker and the AHI derived from in-lab Polysomnography during the same night. | 1 day | 
| Apnea Index-based Negative Predictive Value | The objective is to assess the NPV of the SDB Monitoring function based on RDI stored in the pacemaker or the AHI derived from in-lab Polysomnography during the same night. | 1 day | 
| Safety based on Adverse events | The objective will allow to assess the safety with the summarize all adverse events through 3-month follow-up related to the implant procedure and pacing system or related to any other cause. | 3 months |