Actively Recruiting
First-in-Human Study of the ViewFlex X ICE System for Cardiac Ablation in Adults with Cardiac Arrhythmias
Led by Abbott Medical Devices · Updated on 2026-06-02
500
Participants Needed
8
Research Sites
N/A
Total Duration
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 devices 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
Research Team
B
Ben Gansemer, PhD
A
Amber Miller, PhD
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