Philips Intracardiac Echocardiography (ICE) Clinical Registry

Philips

Status: Completed

Conditions: Mitral Valve Disease; Atrial Fibrillation; Stroke; Aortic Valve Disease; Atrial Septal Defect; Valve Disease, Heart; Tricuspid Valve Disease; Patent Foramen Ovale

Treatments: Device: ICE Image guidance

Study type: Observational

Funder types: Industry

Identifiers

NCT04950192

2019_10745

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

155 participants in 1 patient group

Prospective Observational

Description:

Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance

Treatment:

Device: ICE Image guidance