A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
NCT ID: NCT05970120
Last Updated: 2025-05-20
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-05
Study Completion Date
2024-02-22
Brief Summary
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The purpose of this study is to assess the performance and safety of using the investigational catheter.
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Detailed Description
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Conditions
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Scar-related Atrial Tachycardia
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Ventricular Tachycardia
Premature Ventricular Complex
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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NUVISION NAV Ultrasound Catheter
Participants with five different subgroups (scar-related atrial tachycardia, persistent atrial fibrillation \[PsAF\], paroxysmal atrial fibrillation \[PVF\], ventricular tachycardia \[VT\], and premature ventricular complex \[PVC\]) will be treated using NUVISION NAV ultrasound catheter per investigator's standard of care and followed until 7 days post-procedure.
Group Type
EXPERIMENTAL
NUVISION NAV Ultrasound Catheter
Intervention Type
DEVICE
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
Interventions
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NUVISION NAV Ultrasound Catheter
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone 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 and requirements
* Signed participants Informed Consent Form (ICF)
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
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 of enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
* Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
* Implanted with a mechanical valve
* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention
* 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 the investigator 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 the course of the clinical investigation
* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
* Concurrent enrollment in an investigational study evaluating another device or drug
* 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 of enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
* Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
* Implanted with a mechanical valve
* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention
* 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 the investigator 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 the course of the clinical investigation
* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
* Concurrent enrollment in an investigational study evaluating another device or drug
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Biosense Webster, Inc Clinical Trial
Role: STUDY_DIRECTOR
Biosense Webster, Inc.
Locations
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KBC Split
Split, , Croatia
Site Status
Yitzhak Shamir Medical Center
Ẕerifin, , Israel
Site Status
Centro Cardiologico Monzino
Milan, , Italy
Site Status
Countries
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Croatia
Israel
Italy
References
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Gianni C, Sanchez JE, Della Rocca DG, Al-Ahmad A, Horton RP, Di Biase L, Natale A. Intracardiac Echocardiography to Guide Catheter Ablation of Atrial Fibrillation. Card Electrophysiol Clin. 2021 Jun;13(2):303-311. doi: 10.1016/j.ccep.2021.03.009. Epub 2021 Apr 23.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BWI202104
Identifier Type: OTHER
Identifier Source: secondary_id
BWI202104
Identifier Type: -
Identifier Source: org_study_id
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