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ViewFlex X ICE First-in-Human Study

ViewFlex X ICE First-in-Human Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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 investigation.
  2. Implanted left atrial appendage occluder
  3. Implanted mechanical mitral or tricuspid valve replacement
  4. Implanted intracardiac device within 30 days
  5. Pregnant or nursing
  6. 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.

Study details
    Cardiac Arrhythmias

NCT06772493

Abbott Medical Devices

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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