An interventional study of NUVISION NAV Ultrasound Catheter in Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation and Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the performance and safety of using the investigational catheter.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 30 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Biosense Webster, Inc. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with five different subgroups (scar-related atrial tachycardia, persistent atrial fibrillation \[PsAF\], paroxysmal atrial fibrillation \[PVF\], ventricular tachycardia \[VT\], and premature ventricular complex \[PVC\]) will be treated using NUVISION NAV ultrasound catheter per investigator's standard of care and followed until 7 days post-procedure.
Device: NUVISION NAV Ultrasound Catheter
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.
Time frame: At Day 1
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to 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.
Time frame: From day of index procedure (Day 1) up to 7 days
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures
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.
Time frame: Day 1
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures
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.
Time frame: Day 1
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures
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.
Time frame: Day 1
Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure
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.
Time frame: From day of index procedure (Day 1) up to 7 days
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to 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.
Time frame: From day of index procedure (Day 1) up to 7 days
| Milestone | NUVISION NAV Ultrasound Catheter |
|---|---|
| Started | 30 |
| Participants enrolled with atrial arrhythmia | 24 |
| Participants enrolled with ventricular arrhythmia | 6 |
| Completed | 30 |
| Not completed | 0 |
Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.
| Percentage of participants | NUVISION NAV Ultrasound Catheter |
|---|---|
| Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter | 100.0 (88.4 to 100.0) |
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.
| Participants | NUVISION NAV Ultrasound Catheter |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter | 0 |
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.
| Score on a scale | NUVISION NAV Ultrasound Catheter |
|---|---|
| Initial catheter introduction insert catheter into sheath | 7.0 (6.0 to 7.0) |
| Advance catheter into heart | 7.0 (6.0 to 7.0) |
| Visualize catheter on fluoroscopy | 7.0 (6.0 to 7.0) |
| Catheter performance assessment deflection control | 7.0 (6.0 to 7.0) |
| Deflection reach | 6.5 (5.0 to 7.0) |
| Deflection degree (bi-directional) | 7.0 (5.0 to 7.0) |
| Torqability | 7.0 (6.0 to 7.0) |
| Ability to maintain torque | 7.0 (6.0 to 7.0) |
| Tip rotation knob functionality | 7.0 (6.0 to 7.0) |
| Catheter tip rotation | 7.0 (6.0 to 7.0) |
| Ability to steer catheter within anatomy Manipulate catheter in right atrium (RA) | 7.0 (6.0 to 7.0) |
| Manipulate catheter in left atrium (LA) | 7.0 (5.0 to 7.0) |
| Ability to cross with catheter to LA | 7.0 (6.0 to 7.0) |
| Manipulate catheter in right ventricle (RV) | 7.0 (4.0 to 7.0) |
| Manipulate catheter in left ventricle (LV) | 7.0 (6.0 to 7.0) |
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.
| Score on a scale | NUVISION NAV Ultrasound Catheter |
|---|---|
| Contouring, value of drawing CARTOSOUND contours on 2D ultrasound image | 7.0 (5.0 to 7.0) |
| On dual-plane | 6.0 (5.0 to 7.0) |
| On multi-plane | 6.0 (5.0 to 7.0) |
| General did CARTO integration help you to orient in multi-plane? | 6.0 (4.0 to 7.0) |
| Did CARTO integration help you to orient in 4D? | 6.0 (4.0 to 7.0) |
| Did image on CARTO screen change as predicted when deflecting in anterior and posterior directions? | 6.0 (5.0 to 7.0) |
| How useful was the 'store clip' on CARTO? | 6.0 (4.0 to 7.0) |
| Was troubleshooting information provided by the system helpful? | 6.0 (5.0 to 7.0) |
| Was the green tip overlay on the different planes useful? | 6.0 (6.0 to 7.0) |
| Was the indication of Live vs. Review Modes clear enough? | 6.0 (6.0 to 7.0) |
| How useful was intracardiac echocardiography (ICE) guidance for performing the transseptal puncture? | 7.0 (6.0 to 7.0) |
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.
| Score on a scale | NUVISION NAV Ultrasound Catheter |
|---|---|
| Do you think that the NUVISION NAV ultrasound catheter is an acceptable alternative to TEE? | 7.0 (6.0 to 7.0) |
| What is your overall satisfaction of the NUVISION NAV ultrasound catheter? | 7.0 (6.0 to 7.0) |
| Would you recommend the NUVISION NAV ultrasound catheter to fellow physicians? | 7.0 (4.0 to 7.0) |
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.
| SAEs | NUVISION NAV Ultrasound Catheter |
|---|---|
| Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure | 2 (0.8 to 22.1) |
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.
| Participants | 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 | 0 |
Collected over From baseline up to 7 days after index procedure on Day 1. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NUVISION NAV Ultrasound Catheter | 0/30 (0%) | 2/30 (6.7%) | 2/30 (6.7%) |
| Event | NUVISION NAV Ultrasound Catheter |
|---|---|
| Complete Atrioventricular blockCardiac disorders | 1/30 |
| Vascular access site pseudoaneurysmInjury, poisoning and procedural complications | 1/30 |
| Event | NUVISION NAV Ultrasound Catheter |
|---|---|
| Pericardial EffusionCardiac disorders | 1/30 |
| Delayed Wound HealingInjury, poisoning and procedural complications | 1/30 |
| Age, Continuous(Years) | NUVISION NAV Ultrasound Catheter |
|---|---|
| Mean | 64.1 ± 13.41 |
| Sex: Female, Male(Participants) | NUVISION NAV Ultrasound Catheter |
|---|---|
| Female | 14 |
| Male | 16 |
| Race and Ethnicity Not Collected(Participants) | NUVISION NAV Ultrasound Catheter |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Data sharing details ↗ · yoda.yale.edu
Ran from Sep 2023 to primary completion in Feb 2024, 5 months.
Results were first posted in May 2025, 1 year 2 months after primary completion.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 5 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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