A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Biosense Webster

Status: Completed

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

Treatments: Device: NUVISION NAV Ultrasound Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970120

BWI202104 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NUVISION NAV Ultrasound Catheter

Experimental group

Description:

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.

Treatment:

Device: NUVISION NAV Ultrasound Catheter