A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation
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).
• Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
• Age ≥ 18 years;
• Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:
‣ Jet width ≥ 65% of LVOT
⁃ Vena contracta width of \> 6 mm
⁃ Holodiastolic flow reversal in proximal abdominal/descending aorta
⁃ Jet deceleration rate/Pressure half time \<200ms
⁃ AND, For Grade 3:
⁃ Regurgitant volume ≥ 45-59 ml/beat
⁃ Regurgitant fraction ≥ 40-49%
⁃ EROA ≥ 0.2-0.29 cm2
⁃ OR, For Grade 4:
⁃ Regurgitant volume ≥ 60 ml/beat
⁃ Regurgitant fraction≥50%
⁃ EROA ≥ 0.3 cm2 Note: In cases where not all criteria listed for severe AR are met, the Core Lab will determine severity. Supplemental CMR imaging may be used to substantiate the degree of AR reported by Core Lab on baseline echo when imaging is suboptimal, Doppler parameters are discordant or inconclusive regarding the severity of AR, or when a discrepancy is present between the echo findings and the clinical setting.
• Patients who have symptoms obviously caused by Aortic Regurgitation, such as dyspnea, chest pain, NYHA Class II or higher;
• Patients who are unsuitable for conventional surgery but needs TAVR(It is recommended to refer to the 2020 ACC/AHA Heart Valve Disease Management Guidelines when evaluating the risks of surgical valve surgery),evaluated by the cardiac team (including at least one interventional cardiologist and one cardiovascular surgeon)
• Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System,evaluated by core laboratory;