Table 1 Inclusion and exclusion criteria
Inclusion criteria | |
|---|---|
• | Severe degenerative AV stenosis (calcified AV, effective orifice area <1 cm2 or indexed for body surface area <0.6 cm2/m2, mean AV gradient >40 mmHg, or AV peak systolic velocity >4.0 m/second), and |
• | Symptomatic (dyspnoea ≥NYHA class II, angina pectoris, or syncope), or |
• | Asymptomatic with one or more of the following: |
• Left ventricle posterior wall thickness ≥17 mm | |
• Left ventricular ejection fraction <60% but ≥20% | |
• Atrial fibrillation | |
• | Age ≥70 years |
• | Candidate (clinical and anatomical) for both TAVI and SAVR (as specified by prosthesis manufacture’s guidelines) judged by a multidisciplinary conference |
• | Expected to survive ≥1 year after intervention |
• | Able to provide written informed consent |
Exclusion criteria | |
• | Isolated AV insufficiency |
• | Other significant cardiac valve or septal diseases |
• | Coronary artery comorbidity requiring revascularisation (PCI or CABG) |
• | Intracardiac lesion (thrombus, tumour, vegetation) |
• | Previous open cardiac surgery |
• | Myocardial infarction or PCI within the last year |
• | Stroke or transient ischemic attack within the last 30 days |
• | Renal insufficiency requiring haemodialysis |
• | Pulmonary insufficiency (FEV1 or diffusion capacity <40% of expected) |
• | Active infectious disease requiring antibiotics |
• | Emergency intervention (within 24 hours after the indication for intervention has been made) |
• | Unstable pre-interventional condition requiring inotropic support or mechanical cardiac assistance |
• | A known hypersensitivity or contraindication to nitinol, heparin, clopidogrel, acetyl salicylic acid, or contrast material |
• | Currently participating in an investigational drug or another device study |