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Heart Leaflet Technologies Valve Study

Centro Cardiologico Monzino · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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The study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to removal of the valve, the native valve will be dilated using a standard valve dilation balloon. The Heart Leaflet Technologies(HLT- Heart Leaflet Technologies Inc.) aortic valve device will be released in the native valve and measurements will be taken of the device relative to the anatomic structures of the heart. Once completed, the implant is removed from the native valve and the surgical valve replacement procedure is completed. The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate for patients with aortic valve stenosis.
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