Philips Intracardiac Echocardiography (ICE) Clinical Registry

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Prospective Observational	ICE Image guidance	Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance

Primary Outcome Measures

Name	Time	Method
Technical Success	During procedure	Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure
Imaging Success	During procedure	Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator
Clinical Success	During procedure	Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications.
Number of Participants With Device-related Adverse Event Detection	Procedure through 48 hours or discharge, whichever is earlier	Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier.

Secondary Outcome Measures

Name	Time	Method

Locations (5): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Colorado
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Aurora, Colorado, United States
Northwestern University
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Chicago, Illinois, United States
Mayo Clinic
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Rochester, Minnesota, United States
Texas Cardiac Arrhythmia Research Foundation
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Austin, Texas, United States