NCT05970120Completed
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Source: ClinicalTrials.gov · Last updated 20 May 2025
Brief summary (registry, in English)
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 24 Jul 2023
- Start date
- 5 Sept 2023
- Primary completion date
- 22 Feb 2024
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05970120
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 5 Sept 2023 to the primary completion date, 22 Feb 2024
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- Left ventricular ejection fraction (LVEF) less than or equal to (\<=) 25 percent (%) for ventricular tachycardia (VT) participants
- LVEF \<= 40% for participants with atrial arrhythmia
Age
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Unknown status |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Tsrifin | Israel | Unknown status |
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.