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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01193634 | Clinical Evaluation Of The PARADYM RF Device | PHASE3 | COMPLETED | 75 | — | — | Oct 1, 2010 | Mar 1, 2012 | Jun 18, 2014 | 1 | Germany |
Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.
| Arm | Type | Description |
|---|---|---|
| Paradym RF ICD | EXPERIMENTAL | Active implantable defibrillators range |
| Name | Type | Description |
|---|---|---|
| VR 9250 / DR 9550 / CRT 9750 | DEVICE | Active implantable defibrillators range |
Inclusion Criteria: * In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or rep...