Actively Recruiting
ViewFlex X ICE First-in-Human Study for Cardiac Arrhythmias Using Sensor-Enabled Catheter and Multi Ultrasound Console
Led by Abbott Medical Devices · Updated on 2026-06-02
500
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new version of the ViewFlex X ICE Catheter, Sensor Enabled, along with the ViewMate Multi Ultrasound Console integrated with the EnSite X EP System, called the ViewFlex X ICE System. This early, first-in-human study focuses on patients undergoing cardiac ablation procedures for cardiac arrhythmias. The study aims to assess the device's navigation and imaging capabilities during these procedures and monitor safety through serious adverse events. Participants will undergo a cardiac ablation procedure using the ViewFlex X ICE System, which combines catheter and ultrasound technologies for enhanced visualization of the heart. The study includes different cohorts, each receiving the same intervention. The trial is a single-arm observational study without comparison groups, focusing on real-time use of the device during the procedure. During the study, physicians will assess how well the catheter can be navigated and how effectively it visualizes major heart structures and anatomic markers to guide mapping and ablation. Safety is monitored by tracking any serious adverse events related to the device or procedure until patient discharge. Participants must provide informed consent and will be evaluated for eligibility before enrollment. The study begins in December 2024 and continues until June 2026.
CONDITIONS
Brief 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 such a trial within 30 days prior without pre-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 may limit participation or compliance, or affect scientific validity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day and periprocedural period until discharge
Participants undergo a cardiac ablation procedure using the ViewFlex X ICE System device.
1 procedure visit and monitoring until discharge
Trial Site Locations
Total: 8 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
Ascension St. Vincent's Riverside
Jacksonville, Florida, United States, 32204
Actively Recruiting
4
Research Medical Center
Kansas City, Missouri, United States, 64132
Actively Recruiting
5
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
6
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Ben Gansemer, PhD
A
Amber Miller, PhD
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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