Status:
COMPLETED
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Scar-related Atrial Tachycardia
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the performance and safety of using the investigational catheter.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05970120
Start Date
September 5 2023
End Date
February 22 2024
Last Update
May 20 2025
Active Locations (3)
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1
KBC Split
Split, Croatia, 21000
2
Yitzhak Shamir Medical Center
Ẕerifin, Israel, 7033001
3
Centro Cardiologico Monzino
Milan, Italy, 20138