Trifecta™ Durability Study

Trifecta™ Durability Study

The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.

Inclusion Criteria:

• Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
• Patient requires aortic valve replacement.
• Patient is legal age in host country.
• Patients must be able and willing to provide written informed consent to participate in this investigation
• Patients must be willing and able to comply with all follow-up requirements

Exclusion Criteria:

• Patients with contraindication for cardiac surgery
• Patients who are pregnant.
• Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
• Patient has active endocarditis
• Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 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 has a documented thrombus in left atrium or left ventricle.
• Patient had in the past mitral or tricuspid valve replacement.
• Patient needs mitral and/or tricuspid valve replacement.
• Patient has an Ejection Fraction < 25%
• 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.