Hummingbird ICE Study

NCT07552272 | Not Yet Recruiting FDA Device

• 1 other identifier: SEF-2025-301281
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION; Atrial Fibrillation (AF); Valve Disease, Heart; Atrial Septal Defect; Tricuspid Valve Disease; Patent Foramen Ovale

Keywords

Intracardiac Echocardiography (ICE); VeriSight

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint

  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

• 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

Study Arms (1)

Prospective Observational

Prospective observational subjects undergoing planned cardiac procedures utilizing VeriSight image guidance

Device: ICE Image Guidance

Interventions

ICE Image Guidance DEVICE

VeriSight PRO ICE image guidance

Also known as: VeriSight

Prospective Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age
• Willing to provide written, dated and signed, informed consent
• Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Valve Diseases; Heart Septal Defects, Atrial; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Lucianno Mazzaro, MS

CONTACT

952-266-9969; luciano.mazzaro@philips.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share