Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

This study is evaluating the Free Margin Cusp Sizer (a device called CALIBRATE) for use in aortic valve repair surgery. Aortic valve repair — preserving the patient's own valve rather than replacing it — is increasingly preferred when possible because it avoids the need for lifelong blood thinners or valve replacement. However, achieving a precise repair is technically demanding. The CALIBRATE device helps surgeons measure and size the cusps (leaflets) of the aortic valve intraoperatively, potentially making repairs more consistent and durable. Patients with a tricuspid (three-leaflet) aortic valve who are undergoing elective surgery for aortic valve regurgitation or enlargement of the ascending aorta are enrolled. Researchers will assess whether using the device leads to more successful repairs compared to standard surgical judgment. You may be eligible if... - You are between 18 and 80 years old - You have a tricuspid (three-leaflet) aortic valve - You are scheduled for elective surgery for aortic regurgitation and/or ascending aortic dilatation You may NOT be eligible if... - Your surgery is for an acute aortic dissection - You have active endocarditis of the aortic valve - Your aortic valve has diffuse calcification - You have a bicuspid, unicuspid, or quadricuspid (non-standard) aortic valve Talk to your doctor to see if this trial is right for you.