Trials / Completed
CompletedNCT01115907
Freedom SOLO Stentless Heart Valve Study
Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 251 (actual)
- Sponsor
- Sorin Group USA, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
Detailed description
The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Freedom SOLO Stentless Heart Valve | Freedom SOLO Stentless Heart Valve |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2010-05-04
- Last updated
- 2015-01-26
Locations
15 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01115907. Inclusion in this directory is not an endorsement.