Status:
RECRUITING
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Aortic Valve Regurgitation
Aortic Root Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 th...
Detailed Description
Goal of the study : The objective of this study is to study the safety and reliability of a new surgical instrument, the "Free Margin Cusp Sizer" (patented device). The measuring instrument will be u...
Eligibility Criteria
Inclusion
- Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
Exclusion
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04797572
Start Date
March 22 2021
End Date
December 30 2027
Last Update
May 16 2025
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200