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NCT01240902 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
A NA study, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 1,453
- Enrollment target
NCT01240902: Completed NA study, sponsored by Medtronic Cardiovascular.
NCT01240902 is a NA study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 1,453 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240902, a NA study, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,453 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 high risk for aortic valve surgery and/or very 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 Surgical Aortic Valve Replacement (SAVR)
- DEVICE Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,453 participants |
| Start Date | 2010-12-10 |
| Est. Completion | 2019-05-15 |
| Phase | NA |
What the finished NCT01240902 record still lists
NCT01240902 is an interventional study that assigns participants to a tested intervention. Its 1,453 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Surgical Aortic Valve Replacement (SAVR) is the first listed.
NCT01240902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240902 about?
NCT01240902 is a clinical study titled "Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very 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 high risk for aortic valve surgery and/or very high risk for aortic valve surgery.
What is the current status of trial NCT01240902?
This trial is currently completed. It is a NA study. The enrollment target is 1,453 participants. The study started on 2010-12-10. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT01240902?
The interventions under investigation include: Surgical Aortic Valve Replacement (SAVR) (DEVICE), Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) (DEVICE).
Who is sponsoring clinical trial NCT01240902?
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 NCT01240902's enrollment target sits among peer trials
1,453 68th of 2000 higher than 1,933 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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