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Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures
Sponsor: The Cleveland Clinic
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-08-07
Completion Date
2028-12-31
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
4D ICE Adjunct Imaging
Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.
Locations (1)
Cleveland Clinical Foundation
Cleveland, Ohio, United States