Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures

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

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.

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.

Inclusion Criteria:

1. Be aged above 18 for adult participants
2. Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
3. Be able and willing to give informed consent
4. (For concomitant cases only) Ablation will occur prior to LAAO implantation

Exclusion Criteria:

Potential subjects must not include:

1. Subjects who are currently enrolled in any other investigational clinical studies
2. Subjects with any bleeding diathesis
3. Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
4. Subjects with known intracardiac thrombus
5. Subjects with myocardial infarction within the prior two months
6. Subjects with class IV angina or heart failure
7. Subjects with sepsis or active infection
8. Subjects with immune-deficiency or immune-compromised status
9. Subjects with cerebral ischemic event in the prior six months
10. Subjects with deep vein thrombosis