Randomised trial of transcutaneous versus surgical aortic valve replacement

St George's Healthcare NHS Trust (UK)0 sites657 target enrollmentMay 26, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 26, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

St George's Healthcare NHS Trust (UK)

•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