Philips Intracardiac Echocardiography (ICE) Clinical Registry

NCT04950192 | Completed Results FDA Device

• 1 other identifier: 2019_10745
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (4)

• Technical Success

  Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure

  During procedure

• Imaging Success

  Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator

  During procedure

• Clinical Success

  Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications.

  During procedure

• Number of Participants With 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

Study Arms (1)

Prospective Observational

Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance

Device: ICE Image guidance

Interventions

ICE Image guidance DEVICE

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

Also known as: Philips VeriSight ICE Catheter

Prospective Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (5)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60208, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Heart Valve Diseases; Heart Septal Defects, Atrial; Foramen Ovale, Patent; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Rashmi Ram, Director of Clinical Development
• Organization: Philips IGTD

rashmi.ram@philips.com

719-464-6326

Study Officials

• Rashmi Ram, PhD

  Philips Clinical and Medical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: October 25, 2021
• Primary Completion: December 30, 2022
• Study Completion: July 30, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)