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

NCT07806890 | Recruiting FDA Device

• 1 other identifier: 26-552
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

A-Fib; Left Atrial Appendate Occlusion

Outcome Measures

Primary Outcomes (1)

• Feasibility of 4D ICE Imaging Performance

  A composite score evaluating the overall technical and clinical adequacy of the 4D Intracardiac Echocardiography (ICE) catheter compared to standard-of-care imaging. The composite score is derived from three individual component assessments: Image Quality: Clarity, resolution, and artifact presence. Anatomical Visualization: Ability to clearly identify target cardiac structures. Procedural Guidance: Effectiveness of real-time images in guiding the procedure. Each component is graded by independent reviewers on a 5-point Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent). The final composite score is calculated as the sum of the three component scores, ranging from a minimum of 3 (worst performance) to a maximum of 15 (best performance).

  During the Procedure

Secondary Outcomes (4)

• Image Quality Assessment

  During the Procedure

• Workflow Efficiency

  During the Procedure

• Measurement Acccuacy

  During the Procedure

• Safety Outcomes

  Up to 45 ± 15 days follow-up

Study Arms (1)

4D ICE Adjunct Imaging

EXPERIMENTAL

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.

Device: 4D ICE Adjunct Imaging

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.

4D ICE Adjunct Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Potential subjects must not include:
• Subjects who are currently enrolled in any other investigational clinical studies
• Subjects with any bleeding diathesis
• Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
• Subjects with known intracardiac thrombus
• Subjects with myocardial infarction within the prior two months
• Subjects with class IV angina or heart failure
• Subjects with sepsis or active infection
• Subjects with immune-deficiency or immune-compromised status
• Subjects with cerebral ischemic event in the prior six months
• Subjects with deep vein thrombosis

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Cleveland Clinical Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walid Saliba, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walid Saliba, MD

CONTACT

216-444-6810; salibaw@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: September 8, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)