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, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Requires aortic or mitral 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
Already have had a valve replaced other than that for the scheduled replacement
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 is a prison inmate
Participating in another study
Had the Biocor or Biocor Supra valve implanted but then the device was explanted
