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

Inclusion Criteria1

Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.

Exclusion Criteria6

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.

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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.