RecruitingNCT06772493

ViewFlex X ICE First-in-Human Study

Sponsor

Abbott Medical Devices

Enrollment

500 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

Cardiac Arrhythmias

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

Min Age: 18 Years

Inclusion Criteria4

A patient will be eligible for clinical trial participation if they meet the following criteria:
Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
Plans to undergo any EP procedure utilizing ICE
At least 18 years of age

Exclusion Criteria6

A patient will be excluded from enrollment in the study if they meet any of the following criteria:
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
Implanted mechanical mitral or tricuspid valve replacement
Implanted intracardiac device within 30 days
Pregnant or nursing
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.