Back to resultsEvaluation 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
About this trial
This is an interventional diagnostic trial for Bradycardia
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
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
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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