Bradycardia
Conditions
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
Interventions
DEVICEREPLY 200
REPLY 200 pacemaker
Sponsors
LivaNova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-based sensitivity of breathing troubles | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Apnea Index-based Positive Predictive Value | 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 | 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 | 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. |
Countries
France, Spain
Outcome results
None listed