Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPLY 200 implanted patients | Experimental | REPLY 200 implanted patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REPLY 200 | Device | REPLY 200 pacemaker |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Apnea Index-based Negative Predictive Value |
Not provided
Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| PASCAL DEFAYE, Dr | CHU Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Créteil | France | |||||
Not provided
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | 3 months |
| Grenoble |
| France |
| La Rochelle | France |
| Barcelona | Spain |
| Seville | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |