Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01537718 | Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker | PHASE3 | COMPLETED | 40 | — | — | Mar 1, 2012 | Nov 1, 2012 | Jul 17, 2013 | 5 | France, Spain |
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).
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.
| Arm | Type | Description |
|---|---|---|
| REPLY 200 implanted patients | EXPERIMENTAL | REPLY 200 implanted patients |
| Name | Type | Description |
|---|---|---|
| REPLY 200 | DEVICE | REPLY 200 pacemaker |
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...