跳至主要内容
临床试验/NCT05804240
NCT05804240已完成不适用

Utility of Three-dimensional Transesophageal Echocardiography in Right Ventricular Function Assessment in Surgical Aortic Valve Replacement, Mini-sternotomy Aortic Valve Replacement, and Transcatheter Aortic Valve Replacement

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
3D RVEF (Baseline)

研究概览

简要总结

Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve replacement (AVR): full sternotomy surgical AVR (full-SAVR), mini-sternotomy surgical AVR (mini-SAVR), and transcatheter AVR (TAVR).

详细描述

Objective

Right ventricular (RV) function is known to be a critical factor to determine postoperative outcome in cardiac surgery, and echocardiography plays an important role in RV function assessment. In the previous studies, RV function was reported to be more reduced in surgical aortic valve replacement (SAVR) than transcatheter aortic valve replacement (TAVR), but its assessment was performed by 2-dimensional echocardiography. On the other hand, three-dimensional (3D) echocardiography has been the gold standard to assess RV systolic function (EF: ejection fraction), and its intraoperative use is getting more useful in cardiac surgery given recent technological advance in echocardiography machines. However, realty is that RV function assessment is based on subjective information or traditional RV function indices, mostly due to unfamiliarity of 3D technique.

In this study, the investigators plan to evaluate intraoperative RV function assessment by 3D transesophageal echocardiography (TEE). The investigators will compare 3D RV EF with other traditional RV function indices (RV fractional area change (FAC),, tricuspid annular plane systolic excursion (TAPSE) in full-SAVR, mini-SAVR, and TAVR.

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

  • •Adult patients over 18 years old
  • •Patients who had SAVR, mini AVR, or TAVR

排除标准

  • •Patients' refusal
  • •Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE

研究组 & 干预措施

Surgical aortic valve replacement

Patients who have surgical aortic valve replacement

干预措施: 3D TEE RVEF (Diagnostic Test)

Mini-sternotomy aortic valve replacement

Patients who have mini-sternotomy aortic valve replacement

干预措施: 3D TEE RVEF (Diagnostic Test)

Transcatheter aortic valve replacement

Patients who have transcatheter aortic valve replacement

干预措施: 3D TEE RVEF (Diagnostic Test)

结局指标

主要结局

3D RVEF (Baseline)

时间窗: For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

RVEF assessed using 3D TEE at baseline

%Change in 3D RVEF (From Baseline to Postop)

时间窗: For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

(Postop 3D RVEF-baseline 3D RVEF)\*100/baseline 3D RVEF

次要结局

  • TAPSE (Baseline)(For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.)
  • RV FAC (Baseline)(For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.)
  • %Change in RV FAC (From Baseline to Postop)(For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.)
  • %Change in TAPSE (From Baseline to Postop)(For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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