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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04797572
Other study ID # CALIBRATE TRIAL01
Secondary ID 2020-14DEC/619
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2021
Est. completion date January 1, 2025

Study information

Verified date April 2023
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Laurent de Kerchove, MD, PhD
Phone +32 2 764 41 51
Email laurent.dekerchove@uclouvain.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Device:
Free Margin Cusp Sizer
The free margin cusp sizer will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length.

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

De Kerchove L, Momeni M, Aphram G, Watremez C, Bollen X, Jashari R, Boodhwani M, Astarci P, Noirhomme P, El Khoury G. Free margin length and coaptation surface area in normal tricuspid aortic valve: an anatomical study. Eur J Cardiothorac Surg. 2018 May 1;53(5):1040-1048. doi: 10.1093/ejcts/ezx456. — View Citation

Tamer S, Mastrobuoni S, van Dyck M, Navarra E, Bollen X, Poncelet A, Noirhomme P, Astarci P, El Khoury G, de Kerchove L. Free margin length and geometric height in aortic root dilatation and leaflet prolapse: implications for aortic valve repair surgery. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):124-132. doi: 10.1093/ejcts/ezz132. Erratum In: Eur J Cardiothorac Surg. 2020 Jan 1;57(1):206. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative aortic valve (AV) damage Aortic valve damage caused by the cusp sizer (cusp tear or perforation), rate of conversion from AV repair to AV replacement due to the use of the cusp sizer 30 days
Primary Hospital mortality Patient Survival status at 30 days after surgery 30 days
Primary Major adverse cardiac and cerebrovascular events (MACCE) Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention one year
Primary Aortic valve function Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography One year
Secondary Pre-repair free margin length Length of the 3 leaflets free margin before aortic valve repair Intraoperative
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