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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01362725 | Spinal Cord Stimulation For Heart Failure | PHASE2 | COMPLETED | 20 | — | — | Apr 1, 2011 | Jan 1, 2016 | Feb 4, 2019 | 5 | Australia, Hong Kong +1 |
Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life.
| Arm | Type | Description |
|---|---|---|
| Spinal cord stimulation | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Spinal cord stimulation system | DEVICE | An implantable pulse generator (IPG) will deliver low-intensity electrical pulses which travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation. |
Inclusion Criteria: * Patients has a LVEF between 20% and 35% * Patient is in NYHA Class III or in Ambulatory Class IV * Patient has had a SJM implantable cardioverter defibrillator (ICD) device or a SJM CRT-D device implanted \>90 days and is receiving stable medical therapy for HF (\>90 days) at ...