PILot Aortic Triflo Valve Study

Inclusion Criteria:

• Patient is between 18 and 75 years old.

• Patient with symptomatic aortic valve disease (stenosis and/or regurgitation) whereaortic valve replacement with a mechanical valve is recommended according to thedecision of the site heart team and validated by the independent clinical reviewcommittee.

• Patient with a low surgical mortality risk with EuroSCORE II < 4%.

• Patient with echocardiographic Left Ventricular Ejection Fraction (LVEF) > 35% usingTransthoracic Echocardiogram (TTE).

• Assessment using echocardiography imaging modality of annular suitable for a valveof 21 mm in size and acceptable for the Body Surface Area (BSA) of the patient toavoid any patient prosthesis mismatch.

• Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or havea documented contraindication to aspirin use.

• Patient is geographically stable and willing to return to implanting site forfollow-up visits up to 5 years.

• Patient has been adequately informed of risks and requirements of the clinicalinvestigation and is willing and able to provide informed consent for participation.

• In opinion of the Investigator, the patient has a life expectancy of at least 5years.

Exclusion Criteria:

• Patient has a pre-existing prosthetic valve (including TAVI) or annuloplasty deviceor requires replacement or repair of the mitral, pulmonary or tricuspid valve.

• Patient is maintained on any permanent or long-term anticoagulant therapy (i.e. anyA-fib, deep vein thrombosis, lung embolism, percutaneous coronary intervention (PCI), previous ST-elevation myocardial infarct (STEMI)).

• Patient has a history of vascular-related neurological events (TIA, stroke,intracranial bleeding) occurring within 6 months prior to enrollment.

• Patient has active endocarditis/myocarditis or other systemic infection within 3months of the scheduled surgery.

• Patient has an additional cardiovascular pathology which would increase surgicalrisk of morbidity or mortality.

• Patient is planning another unrelated surgical procedure outside of the cardiac areawithin the next 12 months of study device implantation.

• Patient has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5mg/dL or end stage renal disease requiring chronic dialysis at screening visit.

• Patient presents hemodynamic or respiratory instability requiring inotropic support,mechanical circulatory support, or mechanical ventilation within 30 days prior toplanned valve surgery.

• Patient has active, clinically relevant bleeding disorder (documented leukopenia (WBC < 4.0 x 103/μL), acute anemia (Hgb < 10.0 g/dL or 6 mmol/L), thrombocytopenia (platelet count < 100 x 103/μL) or history of bleeding diathesis or coagulopathy).

• Patient has had prior organ transplant or is currently an organ transplantcandidate.

• Patient is currently participating or participated in the last 30 days in anotherinvestigational device or drug trial.

• Patient who is pregnant, plan to become pregnant during the time of the clinicaltrial or is lactating or patient of childbearing age not taking any effective methodof birth control.

• Patient is considered part of vulnerable population (i.e. prison inmates).

• Patient with documented history of substance (drug or alcohol) abuse within the last 5 years prior to implantation procedure.