Actively Recruiting
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2025-05-16
120
Participants Needed
1
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Tricuspid Aortic Valve operated electively for aortic valve regurgitation and/or ascending aorta dilation
You will not qualify if you...
- Acute aortic dissection
- Diffuse aortic valve calcification
- Aortic valve endocarditis
- Bicuspid, unicuspid, or quadricuspid aortic valves
- Patients under 18 years of age
- Patients over 80 years of age
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
Research Team
L
Laurent de Kerchove, MD, PhD
CONTACT
C
Corinne Coulon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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