Clinical trial NCT05970120: A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Official title: Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar-related Atrial Tachycardia
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Ventricular Tachycardia
Premature Ventricular Complex
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the performance and safety of using the investigational 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

Primary outcomes:
measure: Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
timeFrame: At Day 1
measure: Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
timeFrame: From day of index procedure (Day 1) up to 7 days
Secondary outcomes:
measure: Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures
timeFrame: Day 1
measure: Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures
timeFrame: Day 1
measure: Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures
timeFrame: Day 1
measure: Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure
timeFrame: From day of index procedure (Day 1) up to 7 days
measure: Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
timeFrame: From day of index procedure (Day 1) up to 7 days
Other outcomes:
Locations:
city: Split
country: Croatia
facility: KBC Split
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc Clinical Trial
role: STUDY_DIRECTOR
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