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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537718
First Posted: February 23, 2012
Last Update Posted: July 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LivaNova
  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: Intervention Model: Single Group Assignment
Masking: None (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 LivaNova:

Primary Outcome 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 Outcome 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537718


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

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01537718     History of Changes
Other Study ID Numbers: IBSY04
First Submitted: February 17, 2012
First Posted: February 23, 2012
Last Update Posted: July 17, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes