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NCT03103503 · ClinicalTrials.gov registry record
Plexa ICD Lead Registry
A clinical trial, sponsored by Biotronik.
- Terminated
- Registry status
- 901
- Enrollment target
NCT03103503: Clinical Trial study, sponsored by Biotronik.
NCT03103503 is a clinical trial that was terminated before completion, run by Biotronik. The registered enrollment target is 901 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03103503 was terminated before completion, sponsored by Biotronik.
- TERMINATED
- Registry status
- 901 participants
- Enrollment target
Study Summary
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
Primary Outcome
Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also incl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 901 participants |
| Start Date | 2017-05-18 |
| Est. Completion | 2019-09-27 |
Why NCT03103503 stopped before completion
NCT03103503 is an observational study that tracks outcomes without assigning an intervention. The registered 901 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03103503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03103503 about?
NCT03103503 is a clinical study titled "Plexa ICD Lead Registry". The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
What is the current status of trial NCT03103503?
This trial is currently terminated. The enrollment target is 901 participants. The study started on 2017-05-18. Estimated completion is 2019-09-27.
Who is sponsoring clinical trial NCT03103503?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
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