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Table 1 Inclusion and exclusion criteria

From: The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

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
  1. AV, aortic valve; CABG, coronary artery bypass grafting; FEV1, forced expiratory volume in 1 second; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.