An Observational, Prospective Evaluation of the Trifecta™ Valve

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.

Inclusion criteria

• Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
• Patient is legal age in host country.
• Patient (or legal guardian) has given written informed consent for participation prior to surgery.
• Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion criteria

• Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
• Patient already has a prosthetic valve(s) at a site other than the aortic valve.
• Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
• Patient has an inability or is unwilling to return for the required follow-up visits.
• Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
• Patient has had an acute preoperative neurological event defined as patient has not returned to baseline or has not stabilized 30 days prior to the planned valve implantation surgery.
• Patient is undergoing renal dialysis.
• Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
• Patient is currently participating in the study of an investigational drug or device, or the patient was previously participating in an investigational drug study and has not completed a 30-day wash out period.
• Patient had the Trifecta valve implanted as part of this study, but then had the device explanted.
• Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
• Patient has a life expectancy less than two years.