Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

Recruiting now · Not applicable

Conditions studied: Aortic Valve Regurgitation, Aortic Root Aneurysm

In brief

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.

Key facts

Study ID

NCT04797572

Run by

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

People needed

120

Starts

2021-03-22

Expected to finish

2027-12-30

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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