Trials / Completed
CompletedNCT01651052
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
Detailed description
This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.
Conditions
- Aortic Valve Disorder
- Aortic Valve Insufficiency
- Aortic Valve Stenosis
- Heart Failure
- Coronary Artery Disease
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Heart Valve Surgery | Implant of an aortic valve, Model 11000 |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2012-07-26
- Last updated
- 2019-07-26
- Results posted
- 2019-07-26
Locations
2 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT01651052. Inclusion in this directory is not an endorsement.