Philips Clinical & Medical Affairs Global
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of the VeriSight Pro imaging platform.
This is a prospective, multi-center, open label, observational registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted 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. VeriSight Pro catheter is for use with Philips EPIQ series of ultrasound system. VeriSight Pro is intended for intracardiac and intra-lu…
Inclusion Criteria: * 18 years of age * Willing to provide written, dated and signed, informed consent * Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used Exclusion Criteria: * Contraindicated for ICE catheter placement or considerations that make placement of VeriSight not technically feasible * 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 * Pregnancy
VeriSight PRO ICE image guidance
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