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NCT02679404 · ClinicalTrials.gov registry record
Sorin Universal REgistry on Aortic Valve Replacement
A clinical trial, sponsored by Corcym S.r.l.
- Terminated
- Registry status
- 2,758
- Enrollment target
NCT02679404: Clinical Trial study, sponsored by Corcym S.r.l.
NCT02679404 is a clinical trial that was terminated before completion, run by Corcym S.r.l. The registered enrollment target is 2,758 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02679404 was terminated before completion, sponsored by Corcym S.r.l.
- TERMINATED
- Registry status
- 2,758 participants
- Enrollment target
Study Summary
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU). This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
Primary Outcome
To evaluate the composite rate of site reported valve related MAE defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,758 participants |
| Start Date | 2015-05 |
| Est. Completion | 2021-03 |
Why NCT02679404 stopped before completion
NCT02679404 is an observational study that tracks outcomes without assigning an intervention. Its 2,758 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT02679404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02679404 about?
NCT02679404 is a clinical study titled "Sorin Universal REgistry on Aortic Valve Replacement". Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aort...
What is the current status of trial NCT02679404?
This trial is currently terminated. The enrollment target is 2,758 participants. The study started on 2015-05. Estimated completion is 2021-03.
Who is sponsoring clinical trial NCT02679404?
This trial is sponsored by Corcym S.r.l, which has 4 total clinical trials registered on ClinicalTrials.gov.
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