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

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT07806890

Registry updated: 2026-09-08

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Description

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.

Interventions

4D ICE Adjunct Imaging (Device)
Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.

Eligibility criteria

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

Conditions

Atrial Fibrillation

Locations

Cleveland Clinical Foundation — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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