Trial Outcomes & Findings for A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter (NCT NCT05970120)

Last Updated: 2025-05-20

Results Overview

Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

At Day 1

Results posted on

2025-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	NUVISION NAV Ultrasound Catheter Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Overall Study STARTED	30
Overall Study Participants Enrolled With Atrial Arrhythmia	24
Overall Study Participants Enrolled With Ventricular Arrhythmia	6
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Age, Continuous	64.1 Years STANDARD_DEVIATION 13.41 • n=30 Participants
Sex: Female, Male Female	14 Participants n=30 Participants
Sex: Female, Male Male	16 Participants n=30 Participants

PRIMARY outcome

Timeframe: At Day 1

Population: Per Protocol (PP) analysis set included all enrolled participants who met the study eligibility criteria and in whom assessments were performed with the NUVISION NAV ultrasound catheter.

Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
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 Interval 88.4 to 100.0

PRIMARY outcome

Timeframe: From day of index procedure (Day 1) up to 7 days

Population: Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.

Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter were reported. An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter	0 Participants

SECONDARY outcome

Timeframe: Day 1

Population: PP analysis set included all enrolled participants who met study eligibility criteria and in whom assessments were performed with the NUVISION NAV ultrasound catheter. Here, 'n' (number analyzed) refers to number of participants analyzed for specified categories.

Physician assessment of deployment, maneuverability and navigational features with the NUVISION NAV ultrasound catheter during the study procedures were reported. The physician's feedback was collected after each study procedure for each investigational catheter through a questionnaire-based survey consisting of 15 question/sub-question. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of greater than or equal to (\>=) 4 were considered satisfaction.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Initial catheter introduction insert catheter into sheath	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Advance catheter into heart	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Visualize catheter on fluoroscopy	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Catheter performance assessment deflection control	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Deflection reach	6.5 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Deflection degree (bi-directional)	7.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Torqability	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Ability to maintain torque	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Tip rotation knob functionality	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Catheter tip rotation	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Ability to steer catheter within anatomy Manipulate catheter in right atrium (RA)	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Manipulate catheter in left atrium (LA)	7.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Ability to cross with catheter to LA	7.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Manipulate catheter in right ventricle (RV)	7.0 Score on a scale Interval 4.0 to 7.0
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures Manipulate catheter in left ventricle (LV)	7.0 Score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: Day 1

Population: PP analysis set: all enrolled participants who met study eligibility criteria and in whom assessments were performed with NUVISION NAV ultrasound catheter. Here, 'N' (overall number of participants analyzed) refers to number of participants evaluable for this outcome measure; 'n' (number analyzed) refers to number of participants analyzed for specified categories.

Physician assessment of imaging quality acquired with the NUVISION NAV ultrasound catheter during the study procedures was reported. The quality of image acquired with NUVISION NAV ultrasound catheter and displayed by CARTO software was assessed through physician's feedback on 11 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of \>=4 were considered satisfaction.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=29 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Contouring, value of drawing CARTOSOUND contours on 2D ultrasound image	7.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures On dual-plane	6.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures On multi-plane	6.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures General did CARTO integration help you to orient in multi-plane?	6.0 Score on a scale Interval 4.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Did CARTO integration help you to orient in 4D?	6.0 Score on a scale Interval 4.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Did image on CARTO screen change as predicted when deflecting in anterior and posterior directions?	6.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures How useful was the 'store clip' on CARTO?	6.0 Score on a scale Interval 4.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Was troubleshooting information provided by the system helpful?	6.0 Score on a scale Interval 5.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Was the green tip overlay on the different planes useful?	6.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures Was the indication of Live vs. Review Modes clear enough?	6.0 Score on a scale Interval 6.0 to 7.0
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures How useful was intracardiac echocardiography (ICE) guidance for performing the transseptal puncture?	7.0 Score on a scale Interval 6.0 to 7.0

SECONDARY outcome

Timeframe: Day 1

Physicians overall feedback on the NUVISION NAV ultrasound catheter during the study procedure was reported. The overall feedback on the NUVISION NAV ultrasound catheter was assessed through physician's feedback on 3 question/sub-questions. Each survey question/sub-question included a response option with a Likert scale of 1 to 7 (1=poor and 7=excellent). A score of 4 on the Likert scales indicated the catheter met expectations or was comparable to other devices. Scores of \>=4 were considered satisfaction. TEE is transesophageal echocardiography.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures Do you think that the NUVISION NAV ultrasound catheter is an acceptable alternative to TEE?	7.0 Score on a scale Interval 6.0 to 7.0
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures What is your overall satisfaction of the NUVISION NAV ultrasound catheter?	7.0 Score on a scale Interval 6.0 to 7.0
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures Would you recommend the NUVISION NAV ultrasound catheter to fellow physicians?	7.0 Score on a scale Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: From day of index procedure (Day 1) up to 7 days

Population: Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.

Number of SAEs excluding NUVISION NAV ultrasound catheter related SAE within 7 days of index procedure was reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure	2 SAEs Interval 0.8 to 22.1

SECONDARY outcome

Timeframe: From day of index procedure (Day 1) up to 7 days

Population: Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.

Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter were reported. AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device.

Outcome measures

Outcome measures
Measure	NUVISION NAV Ultrasound Catheter n=30 Participants Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter	0 Participants

Adverse Events

NUVISION NAV Ultrasound Catheter

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NUVISION NAV Ultrasound Catheter n=30 participants at risk Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Cardiac disorders Complete Atrioventricular block	3.3% 1/30 • From baseline up to 7 days after index procedure on Day 1 Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	3.3% 1/30 • From baseline up to 7 days after index procedure on Day 1 Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.

Other adverse events

Other adverse events
Measure	NUVISION NAV Ultrasound Catheter n=30 participants at risk Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC).
Cardiac disorders Pericardial Effusion	3.3% 1/30 • From baseline up to 7 days after index procedure on Day 1 Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.
Injury, poisoning and procedural complications Delayed Wound Healing	3.3% 1/30 • From baseline up to 7 days after index procedure on Day 1 Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter.

Additional Information

Director Medical Affairs

Biosense Webster, Inc.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications and/or presentation of clinical investigation results will be coordinated and governed between Biosense Webster, Inc., the clinical investigation author(s) and if applicable local law. Authorship will be determined prior to development of any manuscript.
Publication restrictions are in place

Restriction type: OTHER