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NCT Number: NCT06772493

ViewFlex X ICE First-in-Human Study

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).

Recruiting

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Key information

Conditions

Cardiac Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Bernards Medical Center, Jonesboro, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

ViewFlex X ICE System

Device

Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System

Primary outcomes

  1. Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.

    Time frame: During the procedure

  2. Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.

    Time frame: during the procedure

  3. Rate of device- or procedure-related serious adverse events that occur through patient discharge.

    Time frame: during the procedure and periprocedurally

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Miller, PhD

CONTACT

[email protected]

Ben Gansemer, PhD

CONTACT

[email protected]

9527152719

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: ViewFlex X FIH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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