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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02113033 | VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients | PHASE2 | COMPLETED | 15 | — | — | Oct 7, 2014 | Sep 20, 2016 | Mar 13, 2018 | 6 | Belgium, France +2 |
Adverse device effects will be sub-classified into device-related or procedure-related, when the adverse event has a generic cause independent from the device itself and occurs within 30 days of the implant procedure.
| Arm | Type | Description |
|---|---|---|
| Treated with Equilia system | EXPERIMENTAL | Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead |
| Name | Type | Description |
|---|---|---|
| Equilia® Vagal Nerve Stimulation | DEVICE | Vagal Nerve Stimulation synchronized with cardiac activity |
Inclusion Criteria: 1. Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF \< 40% 2. Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen 3. Optimal drug ...