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
  Purpose

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


Condition Intervention Phase
Bradycardia
Device: REPLY 200
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REPLY 200 implanted patients
REPLY 200 implanted patients
Device: REPLY 200
REPLY 200 pacemaker

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537718

Locations
France
Creteil, France
Grenoble, France
La Rochelle, France
Spain
Barcelona, Spain
Sevilla, Spain
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: PASCAL DEFAYE, Dr CHU Grenoble, France
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01537718     History of Changes
Other Study ID Numbers: IBSY04
Study First Received: February 17, 2012
Last Updated: July 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ethics Committee

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Bradycardia
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014