Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Treated group Patients in whom the free margin cusp sizer will be used to measure the free margin of the three leaflets of the aortic valve during aortic valve repair. |
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.
|
Outcome Measures
Primary Outcome Measures
- Intraoperative aortic valve (AV) damage [30 days]
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
- Hospital mortality [30 days]
Patient Survival status at 30 days after surgery
- Major adverse cardiac and cerebrovascular events (MACCE) [one year]
Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention
- Aortic valve function [One year]
Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography
Secondary Outcome Measures
- Pre-repair free margin length [Intraoperative]
Length of the 3 leaflets free margin before aortic valve repair
- Post-repair free margin length [Intraoperative]
Length of the 3 leaflets free margin after aortic valve repair
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
Exclusion Criteria:
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Acute aortic dissection;
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Diffuse aortic valve calcification;
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AV endocarditis;
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Bicuspid, unicuspid or quadricuspid aortic valves;
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Patients under the age of 18 years;
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Patients above the age of 80 years.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
- Principal Investigator: Laurent de kerchove, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- CALIBRATE TRIAL01
- 2020-14DEC/619