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

Primary Purpose

Bradycardia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
REPLY 200
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REPLY 200 implanted patients

Arm Description

REPLY 200 implanted patients

Outcomes

Primary Outcome Measures

Event-based sensitivity of breathing troubles
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
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
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
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
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.

Full Information

First Posted
February 17, 2012
Last Updated
July 16, 2013
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT01537718
Brief Title
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
Acronym
DREAM
Official Title
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REPLY 200 implanted patients
Arm Type
Experimental
Arm Description
REPLY 200 implanted patients
Intervention Type
Device
Intervention Name(s)
REPLY 200
Intervention Description
REPLY 200 pacemaker
Primary Outcome Measure Information:
Title
Event-based sensitivity of breathing troubles
Description
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).
Time Frame
1 day
Title
Event-based Positive Predictive Value of breathing troubles
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Apnea Index-based Positive Predictive Value
Description
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.
Time Frame
1 day
Title
Apnea Index-based Negative Predictive Value
Description
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.
Time Frame
1 day
Title
Safety based on Adverse events
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PASCAL DEFAYE, Dr
Organizational Affiliation
CHU Grenoble, France
Official's Role
Principal Investigator
Facility Information:
City
Creteil
Country
France
City
Grenoble
Country
France
City
La Rochelle
Country
France
City
Barcelona
Country
Spain
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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