NCT00475267
Completed
N/A
An Observational, Prospective Evaluation of the Trifecta Valve
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Insufficiency
- Sponsor
- Abbott Medical Devices
- Enrollment
- 203
- Locations
- 5
- Primary Endpoint
- Characterize the hemodynamic performance of the valve.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Detailed Description
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Characterize the hemodynamic performance of the valve.
Time Frame: At required follow-up intervals
Characterize patient NYHA functional classification status.
Time Frame: At required follow-up intervals
Establish adverse event rates.
Time Frame: Ongoing
Study Sites (5)
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