Clinical Trial

Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

Study acronym: CALIBRATE
Recruiting
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Record status
This record was last updated May 16, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-03-10; most recent amendment 2025-05-13.
Status change: Not Yet Recruiting → Recruiting 2023-04-28
Trial Details
NCT Number NCT04797572
Lead Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions Aortic Valve Regurgitation, Aortic Root Aneurysm
Enrollment 120 participants
Start Date 2021-03-22
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-16