4D ICE Imaging for Atrial Fibrillation
(4D-ICE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Walid Saliba, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for people undergoing heart procedures for atrial fibrillation, such as those getting a Watchman device. Participants must be eligible for these standard treatments and able to safely undergo imaging during their procedure.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- 4D Intracardiac Echocardiography (ICE)
Trial Overview
The study is testing the use of a new 4D intracardiac echocardiography (ICE) catheter as an extra imaging tool during heart procedures, alongside the usual transesophageal echocardiogram (TEE). The goal is to see how well it works and how safe it is.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants undergoing left atrial appendage occlusion (LAAO) procedures (with or without concomitant electrophysiology procedures) will receive adjunctive imaging using the 4D ICE catheter while TEE remains the primary imaging modality for procedural guidance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Siemens Corporation, Corporate Technology
Industry Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.