Philips Intracardiac Echocardiography (ICE) Clinical Registry

Sponsor

Philips Clinical & Medical Affairs Global (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04950192

Collaborator

(none)

200

Enrollment

Locations

33.1

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Stroke Valve Disease, Heart Atrial Septal Defect Patent Foramen Ovale Mitral Valve Disease Tricuspid Valve Disease Aortic Valve Disease	Device: ICE Image guidance

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry

Actual Study Start Date :

Oct 25, 2021

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Prospective Observational Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance	Device: ICE Image guidance ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures Other Names: Philips VeriSight ICE Catheter

Arm

Intervention/Treatment

Prospective Observational

Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance

Device: ICE Image guidance

ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures

Other Names:

Philips VeriSight ICE Catheter

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age and willing to provide written, dated and signed, informed consent
Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)

Exclusion Criteria:

Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
If alternate access (as needed instead of femoral) is not viable
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Aurora	Colorado	United States	80045
2	Northwestern University	Chicago	Illinois	United States	60208
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705