Extrait

Background and study aims Aortic stenosis is a narrowing of the valve through which blood flows as it leaves the heart, and affects 13% of people over the age of 70 years. It is usually due to age-related degeneration. If the narrowing becomes severe, chest pain, breathlessness, fluid retention and fainting are common, and the outlook is poor with a high risk of death within 2-3 years. The only effective conventional treatment is surgical replacement of the valve, which involves open chest surgery and temporarily stopping the heart, with use of a heart-lung machine. Surgical results are generally excellent but the elderly often have other medical problems that may result in an increased risk of death and complications. Transcatheter Aortic Valve Implantation (TAVI) is a recently developed technique to implant an artificial aortic valve without major surgery, using a catheter to deliver the valve to the heart through the arteries, which are usually accessed by puncturing the skin in the groin. In some cases, the valve is delivered directly through a small incision in the chest wall. The proposed study will compare TAVI with conventional surgery. Who can participate? Patients aged 70 years or over for whom either treatment is an option but in whom the risks of surgery are considered by an expert local medical team to be intermediate or high. What does the study involve? Each patient who consents to take part will be randomly assigned to receive either TAVI or surgery. Outcomes in each group will be compared to see whether TAVI offers advantages in the short term and whether the long-term results, over 5 years, are as good as surgery. The cost implications for the NHS will be assessed to see if TAVI offers value for money. What are the possible benefits and risks of participating? The results of the study will inform NHS policy for the use of TAVI and guide treatment decisions for future patients. Where is the study run from? University of Leicester (UK) When is the study starting and how long is it expected to run for? August 2013 to October 2022 Who is funding the study? NIHR Health Technology Assessment (UK) Who is the main contact? Dr William D. Toff [email protected]

Critère d'inclusion

• Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery

Liens

• ictrp
• isrctn