Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

Launched by CLINIQUES UNIVERSITAIRES SAINT-LUC- UNIVERSITÉ CATHOLIQUE DE LOUVAIN · Mar 10, 2021

Keywords

ClinConnect Summary

The CALIBRATE clinical trial is studying a new device called the Free Margin Cusp Sizer, which is used during surgery to repair the aortic valve in patients who have conditions like aortic valve regurgitation or aortic root aneurysm. This device helps doctors measure the aortic valve's free margin length, which is important for ensuring the valve works properly after surgery. Participants in the study will be followed for one year to check how well their aortic valve is functioning through regular check-ups and ultrasound tests.

To be eligible for this trial, patients need to be between 65 and 80 years old and must have a specific type of heart valve called a tricuspid aortic valve. Unfortunately, individuals with certain conditions, such as acute aortic dissection or severe valve calcification, cannot participate. If you qualify and choose to join, you can expect to attend several follow-up appointments over the year to monitor your heart health and the success of the procedure.

Gender

ALL

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.