A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Korábbi kezelés

• 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

Más betegség

• Structural heart defect which can only be repaired by cardiac surgery
• 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)
• 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)

Laborértékek

• Left ventricular ejection fraction (LVEF) less than or equal to (<=) 25 percent (%) for ventricular tachycardia (VT) participants
• LVEF <= 40% for participants with atrial arrhythmia

Életkor

• 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

Egyéb

• Pericarditis within 6 months
• Implanted with a mechanical valve
• Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study

• 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