Philips Intracardiac Echocardiography (ICE) Clinical Registry

Stroke Clinical Trial

Official title:

The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04950192
• Other study ID #: 2019_10745
• Status: Active, not recruiting
• Start date: October 25, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age and willing to provide written, dated and signed, informed consent

2. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)

Exclusion Criteria:

1. Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible

2. If alternate access (as needed instead of femoral) is not viable

3. 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• ICE Image guidance
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success	Successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure	During procedure
Primary	Imaging Success	Adequate image quality as determined by the investigator.	During procedure
Primary	Clinical Success	Adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications.	During procedure
Primary	Device-related adverse event detection	Detect device-related adverse events periprocedural through discharge or =48 hours post-procedure, whichever is earlier.	Procedure through 48 hours or discharge, whichever is earlier