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Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Official title: CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2021-03-22
Completion Date
2027-12-30
Last Updated
2025-05-16
Healthy Volunteers
No
Interventions
Free 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.
Locations (1)
Cliniques Universitaires Saint-Luc
Brussels, Belgium