A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

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

Official Title
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Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Conditions
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Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Premature Ventricular Complex

Intervention / Treatment
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* Device: NUVISION NAV Ultrasound Catheter


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NUVISION NAV Ultrasound Catheter<br>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. | Device: NUVISION NAV Ultrasound Catheter<br>* Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Completion of Imaging with the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter | Number of participants who have successfully completed the procedure (imaging with the NUVISION NAV ultrasound catheter) without resort to a non-study ultrasound device will be reported. | Up to 5 months | 
| Number of Participants with Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter | Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect. | Up to 7 days of index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Assessment of Deployment, Maneuverability, Navigational Features and Imaging Quality Acquired with the NUVISION NAV Ultrasound Catheter During the Study Procedures | Physician assessment on deployment, maneuverability, navigational features, and imaging quality acquired with the NUVISION NAV ultrasound catheter will be reported. A post-procedure survey will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized. | Up to 5 months | 
| Number of Participants with Other SAEs (Excluding NUVISION NAV Ultrasound Catheter Related SAE) Within 7 Days of Index Procedure | Number of Participants with other SAEs (excluding NUVISION NAV ultrasound catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect. | Up to 7 days of index procedure | 
| Number of Participants with Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter | Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. An adverse event is any untoward medical occurrence in a participant whether or not related to the investigational device. | Up to 7 days of index procedure |