NCT00475709

Aortic Valve Replacement With Trifecta(TM)

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT00475709

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

An Observational, Prospective Evaluation of the Trifecta Valve

Summary

To confirm the clinical safety and effectiveness of the Trifecta valve.

Eligibility

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.

Disease(s) and\or Condition(s)

Aortic Valve Insufficiency

Regurgitation, Aortic Valve

Aortic Valve Incompetence

Aortic Valve Stenosis

Primary Purpose

TREATMENT

Intervention/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

Sponsor

Abbott Medical Devices