BradycardiaPhase 3DREAMNCT01537718
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
A Phase 3 study testing REPLY 200 in people with Bradycardia, run by LivaNova at 5 sites in 2 countries.
Trial summary
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- REPLY 200
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2012to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
About this study
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
Read the 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
- Conditions
- Bradycardia
- Being tested
- REPLY 200
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REPLY 200Device
REPLY 200 pacemaker
| Study group | Role | What they receive |
|---|---|---|
| REPLY 200 implanted patients | Experimental | REPLY 200 implanted patients Receives: Device: REPLY 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PASCAL DEFAYE, Dr, Principal investigator, CHU Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537718
- Sponsor's protocol ID
- IBSY04
- Acronym
- DREAM
- Status last verified
- Jul 2013
- First submitted
- 17 Feb 2012
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
- ClinicalTrials.gov ID
- NCT01537718
- Acronym / sponsor ID
- DREAM / IBSY04
- Conditions
- Bradycardia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REPLY 200 implanted patients | Experimental | Device: REPLY 200REPLY 200 implanted patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REPLY 200REPLY 200 pacemaker | Device | REPLY 200 implanted patients |
Primary outcome
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.
3 secondary outcomes
Apnea Index-based Positive Predictive Value
Time frame: 1 day
Apnea Index-based Negative Predictive Value
Time frame: 1 day
Safety based on Adverse events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PASCAL DEFAYE, Dr principal investigator
CHU Grenoble, France
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REPLY 200 in people with Bradycardia, run by LivaNova at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-based sensitivity of breathing troubles (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.