NCT00475709
Aortic Valve Replacement With Trifecta(TM)
NA
COMPLETED
NCT00475709
INTERVENTIONAL
An Observational, Prospective Evaluation of the Trifecta Valve
To confirm the clinical safety and effectiveness of the Trifecta valve.
Inclusion Criteria:
* Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
* Legal age.
* Signed informed consent prior to surgery.
* Willing to complete all follow-up requirements.
Exclusion Criteria:
* Pregnant or nursing women.
* Have already had a valve replaced other than the aortic valve.
* Needs another valve replaced.
* Cannot return for required follow-up visits.
* Have active endocarditis.
* Acute preoperative neurological event (such as a stroke).
* Renal dialysis.
* History of substance abuse within one year, or a prison inmate.
* Participating in another study.
* Life expectancy less than two years.
Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis
- TREATMENT
-
- Type: DEVICE
- Name: Trifecta Aortic Heart Valve
- Description: Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
- Arm Group Labels: Trifecta Aortic Heart Valve
- Abbott Medical Devices