About this trial
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
Eligibility criteria
Qualifiers
Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
Age ≥ 18 years;
Jet width ≥ 65% of LVOT
Vena contracta width of > 6 mm
Disqualifiers
Congenital uni- or bicuspid aortic valve morphology;
Previous prosthetic aortic valve (bioprosthesis or mechanical) implant;
Mitral regurgitation or Tricuspid regurgitation> moderate;
Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure;
Trial design
Treatments tested in this trial
- TaurusTrio™ Heart Valve System