Assessment of Utility of Siemens Healthineers 4D ICE and Premium CV System Workflow in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of 4D ICE Imaging Performance
研究概览
简要总结
The purpose of this study is to evaluate the imaging performance and procedural safety of a prototype 4D ICE catheter during real-time intracardiac imaging and to optimize device imaging parameters, compared with current standard imaging modalities.
TEE is the current standard of care and will serve as the primary imaging modality for clinical guidance during the EP and Structural Heart Disease (SHD) procedures. In this research protocol, TEE is not being investigated. ICE will be used as an adjunct imaging modality for research data collection and workflow evaluation only. All procedures will be performed using commercially available, FDA-approved Watchman devices, and no investigational implantable devices will be used. The use of ICE in this study does not modify the approved therapeutic device indication, implantation technique, or standard clinical decision-making.
详细描述
This study is a prospective clinical feasibility study designed to evaluate the imaging performance, workflow efficiency, and safety of a prototype 4D intracardiac echocardiography (ICE) catheter (ACUNAV Luxera) used in conjunction with the Siemens Premium CV ultrasound system during cardiac interventional procedures.
The ACUNAV Luxera 4D ICE system will be used adjunctively while standard-of-care transesophageal echocardiography (TEE) serves as the primary imaging modality. The study aims to determine whether 4D ICE provides comparable image quality and measurement accuracy to TEE, while maintaining procedural safety and enabling optimization of intracardiac imaging workflows.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Be aged above 18 for adult participants
- •Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
- •Be able and willing to give informed consent
- •(For concomitant cases only) Ablation will occur prior to LAAO implantation
排除标准
- •Potential subjects must not include:
- •Subjects who are currently enrolled in any other investigational clinical studies
- •Subjects with any bleeding diathesis
- •Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
- •Subjects with known intracardiac thrombus
- •Subjects with myocardial infarction within the prior two months
- •Subjects with class IV angina or heart failure
- •Subjects with sepsis or active infection
- •Subjects with immune-deficiency or immune-compromised status
- •Subjects with cerebral ischemic event in the prior six months
- •Subjects with deep vein thrombosis
研究组 & 干预措施
4D ICE Adjunct Imaging
Participants undergoing left atrial appendage occlusion (LAAO) procedures (with or without concomitant electrophysiology procedures) will receive adjunctive imaging using the 4D ICE catheter while TEE remains the primary imaging modality for procedural guidance.
干预措施: 4D ICE Adjunct Imaging (Device)
结局指标
主要结局
Feasibility of 4D ICE Imaging Performance
时间窗: During the Procedure
A composite score evaluating the overall technical and clinical adequacy of the 4D Intracardiac Echocardiography (ICE) catheter compared to standard-of-care imaging. The composite score is derived from three individual component assessments: Image Quality: Clarity, resolution, and artifact presence. Anatomical Visualization: Ability to clearly identify target cardiac structures. Procedural Guidance: Effectiveness of real-time images in guiding the procedure. Each component is graded by independent reviewers on a 5-point Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent). The final composite score is calculated as the sum of the three component scores, ranging from a minimum of 3 (worst performance) to a maximum of 15 (best performance).
次要结局
- Image Quality Assessment(During the Procedure)
- Workflow Efficiency(During the Procedure)
- Measurement Acccuacy(During the Procedure)
- Safety Outcomes(Up to 45 ± 15 days follow-up)
研究者
Walid Saliba
Principal Investigator
The Cleveland Clinic