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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor: The Cleveland Clinic
Study ID: NCT07806890
Status: Recruiting

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Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

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.

Study Details

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.

Key Dates

First listed: Sep 8, 2026
Start date: Aug 7, 2026
Status verified: Aug 2026
Primary completion: Dec 31, 2028
Completion: Dec 31, 2028

Study Design

Enrollment: 20 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Arms

Experimental: 4D ICE Adjunct Imaging
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.