Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Trial Parameters
Brief Summary
The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length at different stages of the procedure. The patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by echocardiography (at 6 and 12 months) to assess aortic valve function.
Eligibility Criteria
Inclusion Criteria: * Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation. Exclusion Criteria: * Acute aortic dissection; * Diffuse aortic valve calcification; * AV endocarditis; * Bicuspid, unicuspid or quadricuspid aortic valves; * Patients under the age of 18 years; * Patients above the age of 80 years.