Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VR 9250/ DR 9550/ CRT 9750 · 1 trial · 1 indication
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...
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VR 9250/ DR 9550/ CRT 9750 is an investigational device being studied for the treatment of Heart Failure. It is currently in Phase 3 clinical development, though it is not yet approved. The device is being evaluated in a clinical trial to assess its safety and effectiveness in patients with this condition.
VR 9250/ DR 9550/ CRT 9750 is being developed by LivaNova PLC, a company publicly traded under the ticker symbol LIVN. LivaNova is responsible for the clinical development of this investigational device for Heart Failure.
VR 9250/ DR 9550/ CRT 9750 is in Phase 3 clinical development. It is an investigational device and has not been approved for commercial use. The Phase 3 trial is completed, and the device is being studied for the treatment of Heart Failure.
VR 9250/ DR 9550/ CRT 9750 has one completed Phase 3 clinical trial, identified by NCT number NCT01193634. The trial, titled 'Clinical Evaluation Of The PARADYM RF Device,' enrolled 75 participants with Heart Failure in Germany. The study was not randomized, double-blind, or controlled.
VR 9250/ DR 9550/ CRT 9750 is associated with the PARADYM RF device, as indicated by the clinical trial title 'Clinical Evaluation Of The PARADYM RF Device.' The trial evaluates the PARADYM RF device, which is being studied for Heart Failure in a Phase 3 clinical trial.