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Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

RECRUITINGN/ASponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Actively Recruiting
PhaseN/A
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
Started2021-03-22
Est. completion2026-06-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04797572

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions3

Aortic Root AneurysmAortic Valve RegurgitationHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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