Hummingbird ICE Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICE Image Guidance.
- Who it may be relevant to
- Registry conditions: ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Valve Disease, Heart, Atrial Septal Defect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only during cardiac interventional percutaneous procedures and structural heart procedures. A detailed description of VeriSight can be found in the products' IFU.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. The objective of the study is to collect a comprehensive dataset of raw, de-identified native un-processed ultrasound images and where available collect associated fluoroscopic, CT and MRI images, demographic information and procedural parameters when VeriSight Pro is used in routine percutaneous cardiac intervention procedures and/or ablation procedures. Collected data will be used for development efforts aimed at optimizing image quality, image processing and interoperability of VeriSight Pro imaging platform.
Interventions
- Device ICE Image Guidance
VeriSight PRO ICE image guidance
Primary outcome measures
- Major procedural complication rate [Safety and Tolerability] [Time frame: During procedure]
- Effectiveness (Technical Success) [Time frame: During procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07552272 · SEF-2025-301281