Clinical trial NCT04950192: Philips Intracardiac Echocardiography (ICE) Clinical Registry
Official title: The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Valve Disease, Heart
Atrial Septal Defect
Patent Foramen Ovale
Mitral Valve Disease
Tricuspid Valve Disease
Aortic Valve Disease
Keywords: ICE
Image guided therapy
Structural Heart
Electrophysiology
Intracardiac echocardiography
Atrial Fibrillation
Stroke
Ablation
Valve Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success
timeFrame: During procedure
measure: Imaging Success
timeFrame: During procedure
measure: Clinical Success
timeFrame: During procedure
measure: Number of Participants With Device-related Adverse Event Detection
timeFrame: Procedure through 48 hours or discharge, whichever is earlier
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
Study officials:
affiliation: Philips Clinical and Medical Affairs
name: Rashmi Ram, PhD
role: STUDY_DIRECTOR
References: