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NCT01531374 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
A NA study, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 2,777
- Enrollment target
NCT01531374: Completed NA study, sponsored by Medtronic Cardiovascular.
NCT01531374 is a NA study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 2,777 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531374, a NA study, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,777 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic valve surgery.
Primary Outcome
All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)
Interventions
- DEVICE Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,777 participants |
| Start Date | 2012-02-21 |
| Est. Completion | 2019-11-18 |
| Phase | NA |
What the finished NCT01531374 record still lists
NCT01531374 is an interventional study that assigns participants to a tested intervention. Its 2,777 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 1 intervention - of which Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) is the first listed.
NCT01531374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531374 about?
NCT01531374 is a clinical study titled "Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement". The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic valve surgery.
What is the current status of trial NCT01531374?
This trial is currently completed. It is a NA study. The enrollment target is 2,777 participants. The study started on 2012-02-21. Estimated completion is 2019-11-18.
What interventions are being tested in trial NCT01531374?
The interventions under investigation include: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) (DEVICE).
Who is sponsoring clinical trial NCT01531374?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01531374's enrollment target sits among peer trials
2,777 44th of 2000 higher than 1,957 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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