Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pacing Lead · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 20066 Lead | EXPERIMENTAL | Non-randomized study. Intervention: Device: Pacing Lead |
| Name | Type | Description |
|---|---|---|
| Pacing Lead | DEVICE | Implant and follow up of Model 20066 lead |
Inclusion Criteria: * Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy * Patient has signed and dated the study-specific informed consent form * Patient is 18 years of age or older * Patient is expected to remain available for follow-ups at the investiga...
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Pacing Lead is an investigational medical device being studied for use in Heart Failure. It is a left ventricular lead, model 20066, intended to deliver pacing therapy to the heart. The device is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Pacing Lead is developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical research to evaluate the safety and performance of this left ventricular lead for heart failure patients.
Pacing Lead is in Phase 1 clinical development. It is an investigational device, meaning it has not yet received regulatory approval and is still being studied in clinical trials. The Phase 1 study has been completed, and the device remains under evaluation for heart failure.
Pacing Lead has one completed clinical trial, identified as NCT01365234, titled 'Model 20066 Left Ventricular (LV) Lead Study'. This Phase 1 study enrolled 40 participants with heart failure across Canada, Malaysia, and Sweden. The trial was uncontrolled and not randomized or double-blinded.
Pacing Lead is not FDA approved. It is an investigational device currently in Phase 1 clinical development for heart failure. The completed clinical trial, NCT01365234, was a Phase 1 study, and the device has not yet received marketing authorization from regulatory agencies.