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
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