N/A N=30 Treatment

A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

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

Bottom Line

View on ClinicalTrials.gov: NCT05970120 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

May 2025

Primary outcome: Primary: Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter — 100.0 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NUVISION NAV Ultrasound Catheter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biosense Webster, Inc.
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter	100.0	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter	—	—
SECONDARY Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures	7.0; 7.0; 7.0; 7.0; 6.5; 7.0	—
SECONDARY Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures	7.0; 6.0; 6.0; 6.0; 6.0; 6.0	—
SECONDARY Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures	7.0; 7.0; 7.0	—
SECONDARY Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure	2	—
SECONDARY Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter	—	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05970120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.