This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Replacement of a diseased, damaged, or malfunctioning aortic heart valve
Hôpital de Pontchaillou
Rennes, France
Universitat Herzzentrum Leipzig GmbH
Leipzig, Germany
Deutsches Herzzentrum München
München, Germany
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
To characterize patient NYHA functional classification status
Time frame: CE labelling
To characterize the hemodynamic performance of the valve, as per echocardiography
Time frame: CE labelling
Safety outcomes
Time frame: CE labelling
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