Atrial Fibrillation
Conditions
Keywords
A-Fib, Left Atrial Appendate Occlusion
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.
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.
Interventions
DEVICE4D ICE Adjunct Imaging
Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.
Sponsors
The Cleveland Clinic
Siemens Corporation, Corporate Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be aged above 18 for adult participants 2. Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures. 3. Be able and willing to give informed consent 4. (For concomitant cases only) Ablation will occur prior to LAAO implantation
Exclusion criteria
Potential subjects must not include: 1. Subjects who are currently enrolled in any other investigational clinical studies 2. Subjects with any bleeding diathesis 3. Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible. 4. Subjects with known intracardiac thrombus 5. Subjects with myocardial infarction within the prior two months 6. Subjects with class IV angina or heart failure 7. Subjects with sepsis or active infection 8. Subjects with immune-deficiency or immune-compromised status 9. Subjects with cerebral ischemic event in the prior six months 10. Subjects with deep vein thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of 4D ICE Imaging Performance | 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
| Measure | Time frame | Description |
|---|---|---|
| Image Quality Assessment | During the Procedure | Evaluation of 2D, 4D, and Doppler imaging quality using Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent). |
| Workflow Efficiency | During the Procedure | Procedural workflow metrics including imaging setup and acquisition time |
| Measurement Acccuacy | During the Procedure | Quantitative comparison of ICE-derived measurements (e.g., LAA sizing) with reference imaging (TEE or CT) |
| Safety Outcomes | Up to 45 ± 15 days follow-up | Incidence of device- or procedure-related adverse events |
Countries
United States
Contacts
CONTACTWalid Saliba, MD
PRINCIPAL_INVESTIGATORWalid Saliba, MD
The Cleveland Clinic
Outcome results
None listed