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 Contact: Name: Study Contact; Phone Number: +32 479 97 05 05; Email: nmacours1@its.jnj.com

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
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

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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• Rigatelli G, Dell'Avvocata F, Giordan M, Viceconte N, Osanna RA, Braggion G, Aggio S, Cardaioli P, Chen JP. Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry. J Clin Ultrasound. 2014 Nov-Dec;42(9):534-43. doi: 10.1002/jcu.22177. Epub 2014 Jun 4.
• Medford BA, Taggart NW, Cabalka AK, Cetta F, Reeder GS, Hagler DJ, Johnson JN. Intracardiac echocardiography during atrial septal defect and patent foramen ovale device closure in pediatric and adolescent patients. J Am Soc Echocardiogr. 2014 Sep;27(9):984-90. doi: 10.1016/j.echo.2014.05.017. Epub 2014 Jul 4.
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• Lee W, Griffin W, Wildes D, Buckley D, Topka T, Chodakauskas T, Langer M, Calisti S, Bergstol S, Malacrida JP, Lanteri F, Maffre J, McDaniel B, Shivkumar K, Cummings J, Callans D, Silvestry F, Packer D. A 10-Fr ultrasound catheter with integrated micromotor for 4-D intracardiac echocardiography. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jul;58(7):1478-91. doi: 10.1109/TUFFC.2011.1967.
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• Flautt T, Da-Wariboko A, Lador A, Patel A, Guevara M, Valderrabano M. Left Atrial Appendage Occlusion Without Fluoroscopy: Optimization by 4D Intracardiac Echocardiography. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1592-1594. doi: 10.1016/j.jcin.2022.05.008. No abstract available.
• Kim SS, Hijazi ZM, Lang RM, Knight BP. The use of intracardiac echocardiography and other intracardiac imaging tools to guide noncoronary cardiac interventions. J Am Coll Cardiol. 2009 Jun 9;53(23):2117-28. doi: 10.1016/j.jacc.2009.01.071.
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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.
• D. Fornell, "First-in-Human Experience With Novel 4D ICE Catheter For Catheter Ablation and LAA Closure Procedures," 05 Aug 2021. [Online]. Available: https://www.dicardiology.com/content/first-human-experience-novel-4d-ice-catheter-catheter-ablation-and-laa-closure-procedures. [Accessed 18 Oct 2022].
• 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 (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; 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