Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07806890

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinical Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Oussama Wazni, MD

SUB_INVESTIGATOR

Walid Saliba, MD

CONTACT

[email protected]

216-444-6810

About this study

This study is a prospective clinical feasibility study designed to evaluate the imaging performance, workflow efficiency, and safety of a prototype 4D intracardiac echocardiography (ICE) catheter (ACUNAV Luxera) used in conjunction with the Siemens Premium CV ultrasound system during cardiac interventional procedures.

The ACUNAV Luxera 4D ICE system will be used adjunctively while standard-of-care transesophageal echocardiography (TEE) serves as the primary imaging modality. The study aims to determine whether 4D ICE provides comparable image quality and measurement accuracy to TEE, while maintaining procedural safety and enabling optimization of intracardiac imaging workflows.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of 4D ICE Imaging Performance

    Time frame: During the Procedure

    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).

Secondary outcomes

  1. Image Quality Assessment

    Time frame: During the Procedure

    Evaluation of 2D, 4D, and Doppler imaging quality using Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent).

  2. Workflow Efficiency

    Time frame: During the Procedure

    Procedural workflow metrics including imaging setup and acquisition time

  3. Measurement Acccuacy

    Time frame: During the Procedure

    Quantitative comparison of ICE-derived measurements (e.g., LAA sizing) with reference imaging (TEE or CT)

  4. Safety Outcomes

    Time frame: Up to 45 ± 15 days follow-up

    Incidence of device- or procedure-related adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Walid Saliba, MD

CONTACT

[email protected]

216-444-6810

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Official study 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

Acronym: 4D-ICE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.