A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

NCT05970120 | Completed Results FDA Device

• 1 other identifier: BWI202104
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Scar-related Atrial Tachycardia; Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Ventricular Tachycardia; Premature Ventricular Complex

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures

  Day 1

• Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures

  Day 1

• Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures

  Day 1

• Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure

  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

  From day of index procedure (Day 1) up to 7 days

Study Arms (1)

NUVISION NAV Ultrasound Catheter

EXPERIMENTAL

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

Interventions

NUVISION NAV Ultrasound Catheter DEVICE

Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.

NUVISION NAV Ultrasound Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (3)

KBC Split

Split, 21000, Croatia

Location

Yitzhak Shamir Medical Center

Ẕerifin, 7033001, Israel

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

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MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Results Point of Contact

• Title: Director Medical Affairs
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Biosense Webster, Inc Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: September 5, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

IL (1); CR (1); IT (1)