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

Phase 3

Completed

• Conditions: Bradycardia
• Interventions: Device: REPLY 200

• Registration Number: NCT01537718
• Lead Sponsor: LivaNova

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Study Start: 2012-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-16
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REPLY 200 implanted patients	REPLY 200	REPLY 200 implanted patients

Primary Outcome Measures

Name	Time	Method
Event-based Positive Predictive Value of breathing troubles	1 day	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.
Event-based sensitivity of breathing troubles	1 day	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).

Secondary Outcome Measures

Name	Time	Method
Safety based on Adverse events	3 months	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.
Apnea Index-based Positive Predictive Value	1 day	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.
Apnea Index-based Negative Predictive Value	1 day	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.