Atrial Fibrillation4D-ICENCT07806890
Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures
A study testing 4D ICE Adjunct Imaging in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 4D ICE Adjunct Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinical Foundation
Cleveland, Ohio, 44195
Walid Saliba, MD, 216-444-6810, salibaw@ccf.org
Oussama Wazni, MD
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Being tested
- 4D ICE Adjunct Imaging
- Keywords
- A-Fib, Left Atrial Appendate Occlusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D ICE Adjunct ImagingDevice
Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 4D ICE Adjunct Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the Procedure
Secondary outcomes (4)
Image Quality Assessment
Evaluation of 2D, 4D, and Doppler imaging quality using Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent).
Measured: During the Procedure
Workflow Efficiency
Procedural workflow metrics including imaging setup and acquisition time
Measured: During the Procedure
Measurement Acccuacy
Quantitative comparison of ICE-derived measurements (e.g., LAA sizing) with reference imaging (TEE or CT)
Measured: During the Procedure
Safety Outcomes
Incidence of device- or procedure-related adverse events
Measured: Up to 45 ± 15 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start7 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Walid Saliba, The Cleveland Clinic
- Investigators
- Walid Saliba, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806890
- Sponsor's protocol ID
- 26-552
- Acronym
- 4D-ICE
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07806890
- Acronym / sponsor ID
- 4D-ICE / 26-552
- Conditions
- Atrial Fibrillation
- Keywords
- A-Fib, Left Atrial Appendate Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4D ICE Adjunct Imaging | Experimental | Device: 4D ICE Adjunct ImagingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D ICE Adjunct ImagingUse of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance. | Device | 4D ICE Adjunct Imaging |
Primary outcome
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).
4 secondary outcomes
Image Quality Assessment
Time frame: During the Procedure
Workflow Efficiency
Time frame: During the Procedure
Measurement Acccuacy
Time frame: During the Procedure
Safety Outcomes
Time frame: Up to 45 ± 15 days follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walid Saliba, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D ICE Adjunct Imaging in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walid Saliba, MD (216-444-6810, salibaw@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of 4D ICE Imaging Performance (time frame: During the Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.