Randomised trial of transcutaneous versus surgical aortic valve replacement

St George's Healthcare NHS Trust (UK)0 个研究点目标入组 657 人开始时间: 2009年5月26日最近更新: 2017年9月4日

适应症

试验速览

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•1. After a multidisciplinary meeting, patients (both males ane females) with expected mortality >15% (Euroscore) and/or >10% (Society of Thoracic Surgeons Mortality Risk [STS] score)
•2. Severe aortic stenosis, confirmed by trans-thoracic echocardiography using a combination of measurements of valve area and flow dependent indices (mean gradient >50 mmHg). Low dose dobutamine echocardiography is useful to differentiate between severe and the rare 'pseudo-severe' aortic stenosis in patients with low left ventricular ejection fraction and low gradient.
•3. Severe aortic stenosis, +/- one vessel coronary artery disease amenable to percutaneous intervention
•4. Age >70 (if age <70, need to have other significant comorbidities)
•5. Symptomatic patients with New York Heart Association (NYHA) grade >II
•6. Patients who are able to give consent
•7. If it is thought that risks of mortality and morbidity with surgery outweigh the benefits, the patients will be randomised into cohort B

•1. Aortic regurgitation
•2. Patient preference - TAVI is not recommended for patients who simply refuse surgery on the basis of personal preference
•3. Aortic annulus <18 or >25 mm for balloon expandable and <20 or >27 mm for self-expandable devices
•4. Bicuspid aortic valve
•5. Present of asymmetric heavy valvular calcification
•6. Aortic root dimensions >4.5 cms
•7. Presence of apical left ventricular thrombus
•8. Evidence of acute myocardial infarction <30 days
•9. Hypertrophic cardiomyopathy
•10. Life expectancy <1 year due to non-cardiac causes
•Specific contraindications for transfemoral approach:
•1. Iliac arteries with severe calcification tortuousity and small diameter (6-9 mm), previous aorto-femoral bypass
•2. Severe angulation of aorta and atheroma of the outcome and coaptation, aneurysm of the abdominal aorta with mural thrombus
•3. Presence of bulky atherosclerosis of the ascending aorta and arch
•Specific contraindications for the transapical approach:
•1. Previous surgery of the left ventricle using a patch such as the Dor procedure
•2. Calcified pericardium
•3. Severe respiratory insufficiency

发起方

St George's Healthcare NHS Trust (UK)