ViewFlex X ICE First-in-Human Study

Description

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).

Conditions

Cardiac Arrhythmias

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Study Overview

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Study Details

Study overview

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).

ViewFlex X ICE First-in-Human Study

ViewFlex X ICE First-in-Human Study

Condition
Cardiac Arrhythmias
Intervention / Treatment

-

Contacts and Locations

Jonesboro

St. Bernards Medical Center, Jonesboro, Arkansas, United States, 72401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Kristin Ruffner, PhD, STUDY_DIRECTOR, Abbott

Study Record Dates

2025-12