NCT04950192

Philips Intracardiac Echocardiography (ICE) Clinical Registry

The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.

Detailed description

This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States 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. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter. Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.

Conditions

• Atrial Fibrillation
• Stroke
• Valve Disease, Heart
• Atrial Septal Defect
• Patent Foramen Ovale
• Mitral Valve Disease
• Tricuspid Valve Disease
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	ICE Image guidance	ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-12-30
• Completion: 2023-07-30
• First posted: 2021-07-06
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study