Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
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.
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.