CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Aortic valve function
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
排除标准
- •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.
结局指标
主要结局
Aortic valve function
时间窗: One year
Aortic valve regurgitation and transvalvular gradient by transthoracic echocardiography
Major adverse cardiac and cerebrovascular events (MACCE)
时间窗: one year
Mortality, stroke or transient ischemic attack, major bleeding, cardiac reintervention
Intraoperative aortic valve (AV) damage
时间窗: 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
时间窗: 30 days
Patient Survival status at 30 days after surgery
次要结局
- Pre-repair free margin length(Intraoperative)