ViewFlex X ICE First-in-Human Study

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

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.

Conditions2

Locations7 sites

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