A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Last updated: May 12, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Chest Pain

Fast Heart Rate (Tachycardia)

Treatment

NUVISION NAV Ultrasound Catheter

Clinical Study ID

NCT05970120
BWI202104
BWI202104
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the performance and safety of using the investigational catheter.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with and candidate for clinically-indicated cardiac ablation procedure forthe management of ventricular tachycardia, premature ventricular complex,scar-related atrial tachycardia or atrial fibrillation (participants havingundergone a previous ablation procedure may be included)

  • Signed participants Informed Consent Form (ICF)

  • Able and willing to comply with all pre-, post-, and follow-up testing andrequirements

Exclusion

Exclusion Criteria:

  • Structural heart defect which can only be repaired by cardiac surgery

  • Pericarditis within 6 months

  • Left ventricular ejection fraction (LVEF) less than or equal to (<=) 25 percent (%)for ventricular tachycardia (VT) participants

  • LVEF <= 40% for participants with atrial arrhythmia

  • History of chronic gastro-intestinal medical problems involving the esophagus,stomach and/or untreated acid reflux

  • History of abnormal bleeding and/or clotting disorder

  • Clinically significant infection or sepsis

  • History of stroke or transient ischemic attack (TIA) within the past 6 months ofenrollment

  • Uncontrolled heart failure or New York Heart Association (NYHA) function class IV

  • Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6weeks (42 days)

  • Implanted with a mechanical valve

  • Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or otherabnormality that precludes catheter introduction or manipulation

  • Any of the following within 6 months of enrollment: major surgery except for theindex procedure, myocardial infarction, unstable angina, percutaneous coronaryintervention

  • Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism,or significant coagulation disorder)

  • Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment in this study

  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal),lactating, or who are of childbearing age and plan on becoming pregnant during thecourse of the clinical investigation

  • Categorized as vulnerable population and requires special treatment with respect tosafeguards of well-being

  • Concurrent enrollment in an investigational study evaluating another device or drug

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: NUVISION NAV Ultrasound Catheter
Phase:
Study Start date:
September 05, 2023
Estimated Completion Date:
February 22, 2024

Connect with a study center

  • KBC Split

    Split, 21000
    Croatia

    Site Not Available

  • Sourasky (Ichilov) Medical Center

    Tel Aviv-Yafo, 6423906
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Zerifin, 7033001
    Israel

    Site Not Available

  • Centro Cardiologico Monzino

    Milano, 20138
    Italy

    Site Not Available

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