Trials / Completed
CompletedNCT01437098
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
Detailed description
Non-randomized, prospective, multicenter, single-arm trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MDT-2111 CoreValve for TAVI | CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system. |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2013-04-01
- Completion
- 2018-11-27
- First posted
- 2011-09-20
- Last updated
- 2019-02-15
- Results posted
- 2016-06-06
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01437098. Inclusion in this directory is not an endorsement.