Not currently recruiting at University of California Health

ViewFlex X ICE First-in-Human Study

a study on Cardiac Arrhythmia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Jonathan Hsu, MD (ucsd)
Headshot of Jonathan Hsu
Jonathan Hsu

Description

Summary

This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).

Keywords

Cardiac Arrhythmias, Intracardiac Echocardiography, cardiac electrophysiology, ViewFlex X ICE System

Eligibility

You can join if…

Open to people ages 18 years and up

A patient will be eligible for clinical trial participation if they meet the following criteria:

  1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
  2. Plans to undergo any EP procedure utilizing ICE
  3. At least 18 years of age

You CAN'T join if...

A patient will be excluded from enrollment in the study if they meet any of the following criteria:

  1. Subject is currently participating in another clinical investigation.
  2. Implanted left atrial appendage occluder
  3. Implanted mechanical mitral or tricuspid valve replacement
  4. Implanted intracardiac device within 30 days
  5. Pregnant or nursing
  6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Locations

  • University of California, San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Research Medical Center not yet accepting patients
    Kansas City Missouri 64132 United States
  • St. Bernards Medical Center accepting new patients
    Jonesboro Arkansas 72401 United States

Lead Scientist at University of California Health

  • Jonathan Hsu, MD (ucsd)
    Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 172 research publications. Research interests: Ventricular Tachycardia · Ventricular Arrhythmias · Supraventricular Tachycardia (SVT) · Pacemaker/ICD Implantation · Mechanisms of Arrhythmias · ICDs-Implantable Cardiac Defibrillator · Defibrillator (ICD) · Biventricular Pacemakers · Atrial Flutter

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT06772493
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated