RecruitingNot ApplicableNCT04797572

Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

120 participants

Start Date

Mar 22, 2021

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Regurgitation Aortic Root Aneurysm

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Free Margin Cusp Sizer for people with aortic root aneurysm and aortic valve regurgitation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFree Margin Cusp Sizer

The free margin cusp sizer will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length.