Trials / Completed
CompletedNCT01312779
Magna Mitral - 23mm
Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
Detailed description
This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of CEP Magna Mitral Model 7000TFX | Heart valve surgery: CEP Magna Mitral Model 7000 TFX |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2011-03-11
- Last updated
- 2020-03-18
- Results posted
- 2020-03-03
Locations
6 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01312779. Inclusion in this directory is not an endorsement.