N/A
Completed N=30
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Scar-related Atrial Tachycardia · Persistent Atrial Fibrillation · Paroxysmal Atrial Fibrillation · Ventricular tachycardia
Source: ClinicalTrials.gov NCT05970120 ↗
Enrolled (actual)
30
Serious AEs
6.7%
Results posted
May 2025
Primary outcomePrimary: 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
Summary
The purpose of this study is to assess the performance and safety of using the investigational catheter.
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 |
— | — |
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
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. Informational only — not medical advice.