Trials / Terminated
TerminatedNCT01116037
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
Detailed description
A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ATS 3f Aortic Bioprosthesis | Equine Pericardial Bioprosthesis for replacement of diseased valve |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2010-05-04
- Last updated
- 2017-05-25
- Results posted
- 2017-05-25
Locations
6 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01116037. Inclusion in this directory is not an endorsement.