Evaluation of a Novel Paired-Ring Mitral Annuloplasty Sizing Method and Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Mitral leaflet coaptation length.
研究概览
简要总结
The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.
详细描述
This is a pilot feasibility study of an investigational device. The proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve repair surgery. This device enables the direct measurement of the mitral valve opening. Currently, sizing tools for mitral annuloplasty ring implantation has provide only a rough estimate. The field of cardiac surgery is in need of a precise technique to accomplish the important task of correctly selecting an annuloplasty ring for implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for mitral repair surgery
- •Age 18 years or older
排除标准
- •Adults unable to consent,
- •Pregnant women and prisoners.
- •Emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded.
- •Presence of acute endocarditis infection during the initial screening process
研究组 & 干预措施
Annuloplasty ring sizing tool
A single time use of a novel sizing tool for mitral valve repair surgery
干预措施: Annuloplasy ring sizing device (Device)
结局指标
主要结局
Mitral leaflet coaptation length.
时间窗: During surgery, immediately prior to prosthesis implantation.
Direct measurement of mitral leaflet coaptation length performed with the sizer in position, performed in mm using surgical (disposable) ruler.
Post-procedure, echocardiography measurements - mitral coaptation length.
时间窗: After separation from cardiopulmonary bypass.
Indirect measurement of mitral leaflet coaptation length (mm), using standard intraoperative trans-esophageal echocardiography (TEE) images (measurements performed postoperatively based on archived images).
次要结局
未报告次要终点
研究者
Nikola Dobrilovic
MD
Endeavor Health