A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
Age ≥60 years old;
Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;
previous CABG history;
Coronary ostial lesions（PCI or not）;
Prior aortic valve prosthesis implantation (interventional/surgical, bioprosthetic/mechanical);
Single group
transcatheter aortic valve replacement in severe aortic stenosis
Devicetranscatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis
Device success rate
Device success is defined as - Vascular access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn. - The artificial aortic valve was implanted in an anatomically accurate position. - The artificial aortic valve met the expected requirements (mean transvalvular pressure difference \< 20mmHg or maximum flow rate \< 3m/s; Doppler velocity index \>\_0.25,and less than moderate aortic regurgitation)
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Peijia Medical Technology (Suzhou) Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
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