Clinical trial
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of…
NCT01240902 · Medtronic Cardiovascular, Industry · Completed
Key facts
| NCT number | NCT01240902 |
|---|---|
| Title | 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 |
| Official title | Medtronic CoreValve® U.S. Pivotal Trial |
| Lead sponsor | Medtronic Cardiovascular, Industry |
| Status | Completed |
| Study type | Interventional |
| Conditions | Severe Aortic Stenosis |
| Intervention type | Device |
| Interventions | Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR) |
| Enrollment | 1,453 |
| Start date | Dec 10, 2010 |
| Primary completion | Aug 1, 2014 |
| Completion | May 15, 2019 |
| First posted | Nov 15, 2010 |
| Last update posted | Oct 25, 2022 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: