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Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

Study acronym: CALIBRATE
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Enrollment target: 80 to 120
    • Primary completion date: Aug 1, 2024 to Jun 30, 2026
    • Study completion date: Jan 1, 2025 to Dec 30, 2027
    • Study description revised
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 15, 2021 to Mar 22, 2021
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 388 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04797572
Lead Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions
(from sponsor)		 Aortic Valve Regurgitation, Aortic Root Aneurysm
Related terms Aortic Root Aneurysm, Aortic Valve Insufficiency
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov