NCT04797572 Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
| NCT ID | NCT04797572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Condition | Aortic Valve Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-03-22 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-03-22 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation. Exclusion Criteria: * 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.
Contact & Investigator
Laurent de kerchove
PRINCIPAL INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT04797572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aortic Valve Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04797572 currently recruiting?
Yes, NCT04797572 is actively recruiting participants. Contact the research team at laurent.dekerchove@uclouvain.be for enrollment information.
Where is the NCT04797572 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT04797572 clinical trial?
NCT04797572 is sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The principal investigator is Laurent de kerchove at Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The trial plans to enroll 120 participants.