Hummingbird ICE Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Septal Defect; Patent Foramen Ovale; Valve Disease, Heart; Atrial Fibrillation (AF); Tricuspid Valve Disease; ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION
• Intervention / Treatment: Device: ICE Image Guidance

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Lucianno Mazzaro, MS; Phone Number: 952-266-9969; Email: luciano.mazzaro@philips.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Observational; Prospective observational subjects undergoing planned cardiac procedures utilizing VeriSight image guidance	Device: ICE Image Guidance; VeriSight PRO ICE image guidance; Other Names: VeriSight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During procedure
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)	During procedure

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Intracardiac Echocardiography (ICE); VeriSight
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Foramen Ovale, Patent; Heart Septal Defects, Atrial; Heart Valve Diseases
• Other Study ID Numbers: SEF-2025-301281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data does not need to be shared to meet study objectives.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes