Zhicheng TAVR Robot

Inclusion criteria

• Age ≥65 years old, gender is not limited;
• Patients assessed by a cardiac multidisciplinary team (MDT) expert panel as having severe aortic stenosis and suitable for transcatheter aortic valve replacement;

*Severe aortic stenosis was defined as echocardiographically demonstrated transaortic valve flow velocity ≥4.0 m/s, or transaortic valve pressure differential ≥40 mmHg (1 mmHg=0.133 kPa), or aortic orifice area <1.0 cm2, or effective aortic orifice area index <0.6 cm2/m2; for low-pressure-differential-low-flow rate by dopa-phenobutylamine loading test, Doppler ultrasound evaluation or other imaging means of assessment for those judged to have severe aortic stenosis.

• Have a core laboratory assessment that the patient is anatomically suitable for transcatheter aortic valve replacement;
• Patients who understand the purpose of the trial, voluntarily participate in the trial, sign an informed consent form, and are willing to cooperate in the follow-up.

Exclusion criteria

• Patients whose access or aortic root anatomical pattern is unsuitable for TAVR treatment;
• Poor peripheral arterial conditions that preclude transfemoral TAVR;
• Aortic annulus horizontal pinch angle ≥65° as measured by preoperative MDCT;
• Patients at high risk of coronary obstruction requiring intraoperative coronary protection measures;
• Patients requiring intraoperative delivery with a grapple assist system;
• Previous implantation of a prosthetic aortic valve (bioprosthetic or mechanical);
• Active stage of infective endocarditis or other active infection;
• Combined mitral, tricuspid or severe macrovascular lesions requiring surgical or interventional intervention;
• Echocardiography suggestive of left ventricular thrombus, intracardiac mass or redundant organisms;
• Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g. amyloidosis, haemochromatosis, nodular disease, etc.), constrictive pericarditis;
• Severe obstruction of the left ventricular outflow tract without corrective measures;
• Severe pulmonary hypertension (pulmonary artery systolic pressure >70 mmHg measured by ultrasound);
• Severe right heart dysfunction as suggested by a combined clinical and ultrasound assessment;
• Severe left heart systolic insufficiency (left ventricular ejection fraction <30%);
• Cardiogenic shock or haemodynamic instability requiring ventricular assist device therapy within 30 days prior to enrolment;
• End-stage heart failure (ACC/AHA Stage D), or post cardiac transplantation, or awaiting cardiac transplantation;
• Acute myocardial infarction within 30 days prior to enrolment;
• Has had a stroke within 3 months prior to enrolment;
• Stenosis of the common or internal carotid artery or vertebral artery (>70% stenosis) requiring treatment as recommended by the relevant disciplinary consultation;
• Severe cardiac and aortic disease requiring concomitant treatment, including ascending aortic aneurysm (maximum diameter ≥ 50 mm);
• Severe renal insufficiency (estimated glomerular filtration rate <30mL/min/1.73m2);
• Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months prior to enrolment;
• Severe coagulopathy; Patients with known intolerance to anticoagulant, antiplatelet drugs or anaesthetic drugs; Patients who have participated in other drug or medical device clinical trials prior to enrolment that have not met the primary endpoint; Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial