Phase
Condition
Arrhythmia
Chest Pain
Fast Heart Rate (Tachycardia)
Treatment
NUVISION NAV Ultrasound Catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with and candidate for clinically-indicated cardiac ablation procedure forthe management of ventricular tachycardia, premature ventricular complex,scar-related atrial tachycardia or atrial fibrillation (participants havingundergone 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 andrequirements
Exclusion
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 ofenrollment
Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6weeks (42 days)
Implanted with a mechanical valve
Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or otherabnormality that precludes catheter introduction or manipulation
Any of the following within 6 months of enrollment: major surgery except for theindex procedure, myocardial infarction, unstable angina, percutaneous coronaryintervention
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 theinvestigator 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 thecourse of the clinical investigation
Categorized as vulnerable population and requires special treatment with respect tosafeguards of well-being
Concurrent enrollment in an investigational study evaluating another device or drug
Study Design
Connect with a study center
KBC Split
Split, 21000
CroatiaSite Not Available
Sourasky (Ichilov) Medical Center
Tel Aviv-Yafo, 6423906
IsraelSite Not Available
Yitzhak Shamir Medical Center
Zerifin, 7033001
IsraelSite Not Available
Centro Cardiologico Monzino
Milano, 20138
ItalySite Not Available
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