Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
DREAM
1 other identifier
interventional
40
2 countries
5
Brief Summary
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJuly 17, 2013
July 1, 2013
8 months
February 17, 2012
July 16, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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).
1 day
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.
1 day
Secondary Outcomes (3)
Apnea Index-based Positive Predictive Value
1 day
Apnea Index-based Negative Predictive Value
1 day
Safety based on Adverse events
3 months
Study Arms (1)
REPLY 200 implanted patients
EXPERIMENTALREPLY 200 implanted patients
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (5)
Unknown Facility
Créteil, France
Unknown Facility
Grenoble, France
Unknown Facility
La Rochelle, France
Unknown Facility
Barcelona, Spain
Unknown Facility
Seville, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PASCAL DEFAYE, Dr
CHU Grenoble, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
February 23, 2012
Study Start
March 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
July 17, 2013
Record last verified: 2013-07