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NCT01845103 · ClinicalTrials.gov registry record
The PEARL 8.0 Post-Approval Study
A clinical trial, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.
- Terminated
- Registry status
- 1
- Enrollment target
NCT01845103: Clinical Trial study, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.
NCT01845103 is a clinical trial that was terminated before completion, run by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01845103 was terminated before completion, sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-12 |
Why NCT01845103 stopped before completion
NCT01845103 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01845103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01845103 about?
NCT01845103 is a clinical study titled "The PEARL 8.0 Post-Approval Study". This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
What is the current status of trial NCT01845103?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2013-09. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01845103?
This trial is sponsored by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, which has 2 total clinical trials registered on ClinicalTrials.gov.
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