Philips Intracardiac Echocardiography (ICE) Clinical Registry

Study Overview
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Brief Summary
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The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.

Detailed Description
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This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter. Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.

Official Title
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The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry

Conditions
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Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect, Patent Foramen Ovale, Mitral Valve Disease, Tricuspid Valve Disease, Aortic Valve Disease

Intervention / Treatment
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* Device: ICE Image guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and willing to provide written, dated and signed, informed consent Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU) Exclusion Criteria: Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible If alternate access (as needed instead of femoral) is not viable Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Observational<br>Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance | Device: ICE Image guidance<br>* ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures<br>* Other names: Philips VeriSight ICE Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure | During procedure | 
| Imaging Success | Adequate image quality as determined by the investigator. | During procedure | 
| Clinical Success | Adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. | During procedure | 
| Device-related adverse event detection | Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier. | Procedure through 48 hours or discharge, whichever is earlier | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICE, Image guided therapy, Structural Heart, Electrophysiology, Intracardiac echocardiography, Atrial Fibrillation, Stroke, Ablation, Valve Disease