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Completed

NCT Number: NCT01537718

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Créteil, France

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About this 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REPLY 200

Device

REPLY 200 pacemaker

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Acronym: DREAM

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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