Testing a 4D heart ultrasound catheter during procedures for atrial fibrillation
Tests a 4D ultrasound catheter for imaging inside the heart in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures
Key facts
- Where
- Cleveland, United StatesSee the site
Where in United States
- Cleveland Clinical FoundationCleveland, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Cleveland Clinic
- Trial code
- NCT07806890
- Record updated
- 8 September 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Subjects with myocardial infarction within the prior two months; Subjects with cerebral ischemic event in the prior six months; Subjects with any bleeding diathesis; Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible; Subjects with class IV angina or heart failure; Subjects with sepsis or active infection; Subjects with deep vein thrombosis; Potential subjects must not include:; Subjects who are currently enrolled in any other investigational clinical studies; Subjects with known intracardiac thrombus; Subjects with immune-deficiency or immune-compromised status.