EX-Vivo
Sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder: British Heart Foundation
Collaborator: University of Cambridge
Research Study
Purpose
This study is part of a British Heart Foundation (BHF) Special project Grant. The proposed research aims to test prototype new material for use in making heart valves. Polymeric heart valves potentially offer an attractive alternative to existing materials, combining the improved durability of mechanical valves but with the better performance of bioprosthetic valves with the benefit of not requiring blood thinning medications for life. We have developed a new approach for manufacturing the new material leaflets for prosthetic heart valve (PHV) such that we believe it behaves very similar to a normal native heart valve.
We aim to test the clotting property of the valve material, the tendency of any part of it, in contact with the blood to produce a blood clot this will be assessed by passing blood over the valve material in a special “clotting chamber” and measuring the amount of blood clots thus formed.
Eligible research participants for this study will be recruited via advertisements on the Newcastle Hospitals NHS Foundation Trust Intranet, letters to the members of our NECTAR PCPI- Newcastle Cardiovascular Trials and Research Patient Public and Carer Involvement group and on the NECTAR website- www.nectar.healthcare. They would be aged 50 to 80 years of age and not currently taking medications that would thin the blood including Aspirin (antithrombotic therapy) and who do not have diabetes.
The study will involve one visit to the Clinical Research Facility in the Royal Victoria Infirmary, Newcastle upon Tyne; this visit will take 1 hour. Patients will be required to fast overnight prior to their appointment. A venflon will be inserted and connected to the clotting chamber and a total of 50mls of blood will be taken. The test will take approximately ten minutes, the patient would then be provided with breakfast prior to leaving the department.
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