A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

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

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Scar-related Atrial Tachycardia; Premature Ventricular Complex
• Intervention / Treatment: Device: NUVISION NAV Ultrasound Catheter

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21000
    • KBC Split
• Israel
  • Zerifin, Israel, 7033001
    • Yitzhak Shamir Medical Center
• Italy
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter	Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.	At Day 1
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 were reported. An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	From day of index procedure (Day 1) up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures	Physician assessment of deployment, maneuverability and navigational features with the NUVISION NAV ultrasound catheter during the study procedures were reported. The physician's feedback was collected after each study procedure for each investigational catheter through a questionnaire-based survey consisting of 15 question/sub-question. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of greater than or equal to (>=) 4 were considered satisfaction.	Day 1
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures	Physician assessment of imaging quality acquired with the NUVISION NAV ultrasound catheter during the study procedures was reported. The quality of image acquired with NUVISION NAV ultrasound catheter and displayed by CARTO software was assessed through physician's feedback on 11 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of >=4 were considered satisfaction.	Day 1
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures	Physicians overall feedback on the NUVISION NAV ultrasound catheter during the study procedure was reported. The overall feedback on the NUVISION NAV ultrasound catheter was assessed through physician's feedback on 3 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of >=4 were considered satisfaction. TEE is transesophageal echocardiography.	Day 1
Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure	Number of SAEs excluding NUVISION NAV ultrasound catheter related SAE within 7 days of index procedure was reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	From day of index procedure (Day 1) up to 7 days
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 were reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device.	From day of index procedure (Day 1) up to 7 days

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Biosense Webster, Inc Clinical Trial, Biosense Webster, Inc.

Publications and helpful links

General Publications

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• A. C. Lin and D. J. Wilber, Complications Associated With Radiofrequency Catheter Ablation, in Radiofrequency catheter ablation of cardiac arrhythmias: basic concepts and clinical applications, S. H. a. D. Wilber, Ed., Armonk, N.Y.: Futura Publishing Co. Inc., 2000, pp. 737-746

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Atrial Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: BWI202104 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes