Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker (DREAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01537718
First received: February 17, 2012
Last updated: July 16, 2013
Last verified: July 2013

February 17, 2012
July 16, 2013
March 2012
November 2012   (final data collection date for primary outcome measure)
  • Event-based sensitivity of breathing troubles [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 sensivity of breathing troubles [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Complete list of historical versions of study NCT01537718 on ClinicalTrials.gov Archive Site
  • Apnea Index-based Positive Predictive Value [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
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.

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

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Bradycardia
Device: REPLY 200
REPLY 200 pacemaker
Experimental: REPLY 200 implanted patients
REPLY 200 implanted patients
Intervention: Device: REPLY 200
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Spain
 
NCT01537718
IBSY04
No
Sorin Group
Sorin Group
Not Provided
Principal Investigator: PASCAL DEFAYE, Dr CHU Grenoble, France
Sorin Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP