Trials / Completed
CompletedNCT01531374
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
Medtronic CoreValve® Continued Access Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,777 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) |
Timeline
- Start date
- 2012-02-21
- Primary completion
- 2015-11-01
- Completion
- 2019-11-18
- First posted
- 2012-02-10
- Last updated
- 2022-10-25
- Results posted
- 2017-07-18
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01531374. Inclusion in this directory is not an endorsement.