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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

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

Interventions

  • Device: REPLY 200
    • REPLY 200 pacemaker

Arms, Groups and Cohorts

  • Experimental: REPLY 200 implanted patients
    • REPLY 200 implanted patients

Clinical Trial Outcome Measures

Primary Measures

  • Event-based sensitivity of breathing troubles
    • Time Frame: 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).
  • Event-based Positive Predictive Value of breathing troubles
    • Time Frame: 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.

Secondary Measures

  • Apnea Index-based Positive Predictive Value
    • Time Frame: 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
    • Time Frame: 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.
  • Safety based on Adverse events
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LivaNova
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • PASCAL DEFAYE, Dr, Principal Investigator, CHU Grenoble, France

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