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.
18 years of age
Willing to provide written, dated and signed, informed consent
Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used
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
All subjects age 18 and older that are scheduled for and will undergo a planned cardiac interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing to sign an informed consent without meeting any of the exclusion criteria set and meeting all the inclusion criteria set forth in the protocol will be included in the population for analyses.
Case-only
Prospective
ICE Image Guidance
DeviceVeriSight PRO ICE image guidance
Major procedural complication rate [Safety and Tolerability]
Major procedural complication rate (Cardiac perforation, pericardial tamponade, pericardial effusion requiring intervention, major vascular complication requiring intervention or transfusion, procedural related stroke, death or device embolization) related to the device (Verisight Pro)
Effectiveness (Technical Success)
Technical success of VeriSight Pro is defined as: Successful guidance of the treating device to the intended target region, and generation of intracardiac images adequate to visualize the target anatomy relevant to the planned intervention. Technical success is assessed by the Investigator or qualified designee at procedure end.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
