跳至主要内容
临床试验/NCT04600245
NCT04600245Unknown不适用

Evaluation of CARTOSOUND FAM Software for Accurate Three Dimensional Reconstruction of the Left Atrium in Patients Referred for Atrial Fibrillation Ablation

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Anatomy accuracy - LAA position

研究概览

简要总结

The aim of the present study is to compare the LA reconstruction obtained with CartoSound-FAM software and The M-FAM software to the Carto Merge 3D reconstruction and FAM in consecutive patients referred for AF ablation.

详细描述

A precise reconstruction of the left atrium (LA), the pulmonary veins (PV) and the left atrial appendage (LAA) is of critical importance in order to achieve efficient and safe results in atrial fibrillation ablation. Currently the LA reconstruction methods are mainly based on techniques as Fast Anatomical Mapping (FAM) and cardiac CT merging. FAM mapping requires catheter manipulation by a skilled operator and it is time consuming. The raw anatomy obtained with FAM requires also a post imaging refinement of the LA surfaces by shaving of the image with sculpting tools before the initiation of the ablation and throughout the procedure. A drawback of this approach is represented by the frequent lack of accuracy in the definition of critical areas of the LA during the ablation as PV antrum, left PVs-LAA appendage ridge, PV carinas. An alternative approach is based on the merging of the FAM reconstruction to a CT scan of the left atrium acquired before the procedure (Carto Merge). The advantage of this technique is a far better definition of the LA anatomy including PV antrum, PV sizing, angle of insertion on the LA of the PV and the recognition of PV anomalies (PV common os, separated branches, additional PVs). The drawbacks of these approaches are mainly related to the exposure of the patients to contrast media during the cardiac CTA and the additional costs of the CT scan to the entire budget of the procedure.

The CARTOSOUND® FAM algorithm is a model-based algorithm, developed using the Machine Learning methodology, which reconstructs a 3D volume of the Left Atrium (LA) anatomies (LA Body, Left Atrial Appendage - LAA, Left Inferior Pulmonary Vein - LIPV, Left Superior Pulmonary Vein - LSPV, Right Superior Pulmonary Vein - RSPV, and Right Inferior Pulmonary Vein - RIPV) based on a series of 2D ultrasound frames acquired from the Right Atrium - RA (Fossa Ovalis) and the RVOT. In addition to the 3D volume reconstructed, the CARTOSOUND® FAM algorithm generates 2D automatic contours that are overlaid on the corresponding 2D ultrasound frames and provides auto segmentation of the Left Atrium (LA) anatomies. The advantages of the CARTOSOUND FAM are related to the shortening of mapping required to achieve an entire LA reconstruction and better resolution of the LA anatomy compared to FAM.

The aim of the present study is to compare the LA reconstruction obtained with CartoSound-FAM software and The M-FAM software to the Carto Merge 3D reconstruction and FAM in consecutive patients referred for AF ablation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Male and female >18 years old.
  • Subjects must provide written informed consent to participate in the study.
  • Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

排除标准

  • Pregnant women.
  • Patients with iodine contrast media allergy
  • Patients with renal failure (GFR <60ml/min)

结局指标

主要结局

Anatomy accuracy - LAA position

时间窗: 1 week

The LAA position will be compared for between CT and CartoSound-FAM

Procedure time

时间窗: 1 day

The time required to map the LA in order to obtain a CartoSound-FAM and the M-FAM reconstructions (in minutes).

Anatomy accuracy - LAA size

时间窗: 1 week

The LAA size and position will be compared for between CT and CartoSound-FAM (diameter in centimeters)

Anatomy accuracy - LA size

时间窗: 1 week

The LA will be compared for between CT and CartoSound-FAM

Anatomy accuracy - PV position

时间窗: 1 week

The PV position will be compared for between CT and CartoSound-FAM

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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