CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Aortic valve function
Study Overview
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Free Margin Cusp Sizer (Device)
Outcomes
Primary Outcomes
Aortic valve function
Time Frame: One year
Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: one year
Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention
Intraoperative aortic valve (AV) damage
Time Frame: 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
Time Frame: 30 days
Patient Survival status at 30 days after surgery
Secondary Outcomes
- Pre-repair free margin length(Intraoperative)