跳至主要内容
临床试验/NCT05743322
NCT05743322Unknown不适用

The Usefulness of Pre-procedural 3D Print of Both Atria to Plan Transseptal Puncture for the Left Atrial

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Number of recaptures of the device

研究概览

简要总结

The aim of the study is to assess the usefulness of pre-procedural 3D printing of both atria to plan optimum site for transseptal puncture for the left atrial appendage closure.

详细描述

All patients referred for the left atrial appendage closure will be enrolled. Before the procedure, cardiac CT (computed tomography) will be done. Using cardiac CT, segmentation procedure will be performed. The segmented 3D biatrial reconstruction will be exported in the stereolithography (STL) format and then printed out.

Before every procedure as a part of pre-procedural planning, TSP puncture will be simulated in vitro using the three-dimensional printing (3DP) models and a 12 Fr delivery sheath. Six holes (TSP locations) through the intraatrial septum will be performed from the right side of the septum by a cordless drill. The puncture sites will be localised as follows: three in the cranial part of the fossa ovalis (FO) (anteriorly just behind the aortic root, in the middle and posteriorly) and three in the caudal portion of the FO in the identical way. The delivery sheath will be inserted through each preformed hole and its distal tip was positioned in the LAA (10 - 20 mm deep). The relationship of the sheath and the proximal LAA segment will be evaluated in two orthogonal views. Two criteria had to be met in both views to classify the puncture site as optimal: (1) a central sheath position and (2) a coaxial sheath position (the angle with the LAA ostium axis not exceeding 30°).

All procedures will be done by experienced operators according to the actual guidelines. Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) will be used. Before the procedure, each operator received a recommendation regarding the optimal puncture sites. In ICE guided cases, based on the LA anatomical structures visible in the projection plane during TSP, the puncture site was classified as posterior (left-sided pulmonary veins visible), middle (coumadin ridge visible), or anterior (LAA and mitral annulus visible). In TEE guided procedures mainly mid-oesophageal aortic valve short axis view (∼ 25-45°) and mid-oesophageal bicaval view (∼ 90-110°) will be used. Depending on in which third of the interatrial septum the puncture was performed, it will be classified as anterior, middle, or posterior (aortic valve short axis view). The bicaval projection showed the cranio-caudal localization.

The 3DP models were not used for device sizing, it was done based on the CT data and intra-procedural angiography according to the performing physicians' preferences.

The procedural difficulty will be assessed by the operator (focused on the alignment of the delivery assembly with the LAA axis). Furthermore, the number of recaptures of devices will be analyzed, as well as the number of unsuccessful procedures and procedural complications. Additional golas of the project are: to analyse the distribution of optimal puncture sites and to correlate CT 2D measurements with those findings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • atrial fibrillation (paroxysmal or non-paroxysmal)
  • CHA2DS2VASc more or equal 2 (Congestive heart failure, Hypertension, Age > 75 years, Diabetes, Stroke, Vascular disease, Age > 65 years, female sex)
  • Contraindications for long-term anticoagulation

排除标准

  • allergy to contrast dye
  • non-willingness to participate
  • left atrial appendage thrombus

结局指标

主要结局

Number of recaptures of the device

时间窗: It will be assessed immediately after the procedure, i.e. on the day of the procedure

Number of recaptures of the device

Procedure satisfaction, scale 1-3 (1- optimum, 2-possible to implant, 3-impossible to implant)

时间窗: It will be assessed immediately after the procedure, i.e. on the day of the procedure

The satisfaction with the transseptal puncture for the purpose of the procedure, assessed by the operator

Angle between the delivery sheath and the LAA axis

时间窗: It will be assessed immediately after the procedure, i.e. on the day of the procedure

the axis between the delivery sheath with the axis of the left atrial appendage will be analysed in two orthogonal projections

次要结局

  • Procedural complications(Until 30 days after the procedure)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pavel Osmancik

head of the dept. of cardiac arrhythmias, Charles University and University Hospital Kralovske Vinohrady

Charles University, Czech Republic

研究点 (2)

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