ViewFlex X ICE First-in-Human Study

Last updated: January 27, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Circulation Disorders

Treatment

ViewFlex X ICE System

Clinical Study ID

NCT06772493
ABT-CIP-10528
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 clinicalinvestigation-related procedure.

  2. Plans to undergo any EP procedure utilizing ICE

  3. At least 18 years of age

Exclusion

Exclusion Criteria:

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, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: ViewFlex X ICE System
Phase:
Study Start date:
December 16, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • St. Bernards Medical Center

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • University of California, San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • Research Medical Center

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

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