Actively Recruiting
ViewFlex X ICE First-in-Human Study
Led by Abbott Medical Devices · Updated on 2026-03-19
500
Participants Needed
7
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ViewFlex X ICE First-in-Human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
- Plans to undergo any electrophysiology procedure utilizing intracardiac echocardiography (ICE).
- At least 18 years of age.
You will not qualify if you...
- Currently participating in another clinical trial with an active treatment arm or participated in one within 30 days prior to enrollment without sponsor approval.
- Implanted mechanical mitral or tricuspid valve replacement.
- Implanted intracardiac device within 30 days.
- Pregnant or nursing.
- Presence of other anatomic, medical, social, or psychological conditions that could limit participation, compliance, or affect study results as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
3
Research Medical Center
Kansas City, Missouri, United States, 64132
Actively Recruiting
4
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
5
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Ben Gansemer, PhD
CONTACT
A
Amber Miller, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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