Study of the Free Margin Cusp Sizer Device for Measuring Aortic Valve Edges During Valve Repair Surgery Safety and Performance Evaluation with One-Year Follow-Up

What this Trial Is About

Researchers are evaluating the safety and performance of a new surgical device called the Free Margin Cusp Sizer, designed to aid in aortic valve repair and valve-sparing procedures. This device helps measure the length of the free edge of the aortic valve cusps during surgery, offering a more precise and objective approach compared to the traditional visual estimation. The study is prospective and single-center, focusing on patients with tricuspid aortic valves undergoing elective surgery for valve regurgitation or aortic dilation. The Free Margin Cusp Sizer is used intraoperatively as a caliper to measure the free margin length of the three leaflets of the aortic valve during repair. The study includes one group of patients who will have this device applied during their procedure. Follow-up includes clinical assessments at 1, 2, 6, and 12 months post-surgery, with echocardiographic evaluations at 6 and 12 months to monitor valve function and repair outcomes. Participants will undergo standard preoperative cardiac evaluations including transthoracic and transesophageal ultrasounds, intraoperative imaging before and after repair, and routine postoperative consultations. Researchers will track safety outcomes such as hospital mortality within 30 days, major cardiac and cerebrovascular events over one year, and intraoperative valve damage. The study aims to provide detailed measurements of valve cusp repair and function with up to one year of participant follow-up.

Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)