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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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• 4D ICE Adjunct Imaging (device)

Sponsor: The Cleveland Clinic · Participants: 20 · Started: Aug 7, 2026

Contact the study team

• Walid Saliba, MD · Phone: 216-444-6810

Official record on ClinicalTrials.gov — NCT07806890

Locations in the U.S.

Conditions

• Atrial Fibrillation

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.