Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)

Study Overview
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Brief Summary
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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.

Detailed Description
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Goal of the study : The objective of this study is to study the safety and reliability of a new surgical instrument, the Free Margin Cusp Sizer (patented device). The measuring instrument will be used during aortic valve repair procedures to measure the length of the free edge of the aortic cusps. State of the art : Currently, aortic valve repair is done by visual estimation and requires a great level of experience from the surgeon. We proposed to develop an objective cusp repair technique based on the measurement of the free edge by a dedicated sizer. The measuring instrument will give the objective difference in millimeters between the normal cusp and the one with prolapse. This will then be quantitatively plicatured to correct its excess length. This new technique will allow less experienced surgeons or those in the process of learning objective guidance of valve repair. The objective measure of the free edge length may also orient the sizing of the Dacron graft used for valve sparing root replacement. Study evaluation criteria: Hospital mortality (mortality at 30 days), MACCE at one year: mortality, cerebrovascular accident or transient ischemic attack, major hemorrhage, cardiac reoperation Echocardiographic results at discharge from hospital and at 6 months or one year Material and methods: Single-center, prospective, non-randomized study Patient source: Patients operated for aortic valve repair or aortic valve sparing surgery at Cliniques Universitaires Saint-Luc (CUSL), Brussels Number of patients to be included: 80, study duration: 4 years, inclusion period: 3 years, follow-up: 1 year Inclusion criteria: patient with a tricuspid aortic valve operated electively for aortic valve insufficiency or dilation of the ascending aorta Exclusion criteria: acute aortic dissection, diffuse aortic valve calcification, endocarditis, bicuspide, unicuspid or quadricuspid aortic valve, patient under 18 and over 80 Data acquisition and patient follow-up: The examinations carried out within the framework of this study are the same as those carried out routinely during the preoperative cardiac assessment and clinical follow-up after aortic valve repair: Preoperative cardiovascular examination including TTE (transthoracic ultrasound) / TEE (transesophageal ultrasound) Intraoperative TEE pre and post aortic valve repair TTE at discharge TTE between 6 months and one year postoperatively 1 month post-operative consultation (outpatient surgery) Consultation 1 to 2 months postoperative (referring cardiologist) Consultation 6-12 months postoperative (referring cardiologist) (if necessary, phone contact with the patient at 12-14 months)

Official Title
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CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery

Conditions
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Aortic Valve Regurgitation, Aortic Root Aneurysm

Intervention / Treatment
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* Device: Free Margin Cusp Sizer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treated group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Hospital mortality | Patient Survival status at 30 days after surgery | 30 days | 
| Major adverse cardiac and cerebrovascular events (MACCE) | Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention | one year | 
| Aortic valve function | Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-repair free margin length | Length of the 3 leaflets free margin before aortic valve repair | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve repair, Valve sparing surgery, Trileaflet aortic valve