Back to Trials
NCT06772493Recruiting

ViewFlex X ICE First-in-Human Study

Abbott Medical Devices

Start Date

12/16/2024

Completion Date

6/1/2026

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

Age Range: 18 years to No maximum

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 clinical investigation-related procedure. 2. Plans to undergo any EP procedure utilizing ICE 3. At least 18 years of age 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 trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor 2. Implanted mechanical mitral or tricuspid valve replacement 3. Implanted intracardiac device within 30 days 4. Pregnant or nursing 5. 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.

Interventions

DEVICE

ViewFlex X ICE System

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Cardiac Arrhythmias

Locations

St. Bernards Medical Center

Jonesboro, Arkansas 72401

United States

University of California, San Diego

La Jolla, California 92037

United States

Ascension St. Vincent's Riverside

Jacksonville, Florida 32204

United States

Research Medical Center

Kansas City, Missouri 64132

United States

NYU Langone Health

New York, New York 10016

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Houston Methodist Hospital

Houston, Texas 77030

United States