Aortic Valve Incompetence, Aortic Valve Insufficiency, Aortic Valve Stenosis, Regurgitation, Aortic Valve
Conditions
Keywords
aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation
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.
Interventions
Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize the hemodynamic performance of the valve. | At required follow-up intervals |
| Establish adverse event rates. | Ongoing |
| Characterize patient NYHA functional classification status. | At required follow-up intervals |
Countries
Canada
Outcome results
None listed