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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
REPLY 200 pacemaker
Unnamed facility
Créteil, France
Unnamed facility
Grenoble, France
Unnamed facility
La Rochelle, France
Unnamed facility
Barcelona, Spain
Unnamed facility
Seville, Spain
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).
Time frame: 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.
Time frame: 1 day
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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