Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Aortic Valve Replacement With Trifecta(TM)
