Scar-related Atrial TachycardiaNCT05970120
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
A study testing NUVISION NAV Ultrasound Catheter in people with Scar-related Atrial Tachycardia and Persistent Atrial Fibrillation, run by Biosense Webster, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to assess the performance and safety of using the investigational catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- NUVISION NAV Ultrasound Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Sep 2023to 22 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Premature Ventricular Complex
- Being tested
- NUVISION NAV Ultrasound Catheter
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Ventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUVISION NAV Ultrasound CatheterDevice
Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
| Study group | Role | What they receive |
|---|---|---|
| NUVISION NAV Ultrasound Catheter | Experimental | 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. Receives: Device: NUVISION NAV Ultrasound Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From day of index procedure (Day 1) up to 7 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From day of index procedure (Day 1) up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Sep 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Scar-related Atrial TachycardiaStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc Clinical Trial, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970120
- Sponsor's protocol ID
- BWI202104
- Other IDs
- BWI202104
- Status last verified
- May 2025
- First submitted
- 24 Jul 2023
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Publications
Perk G, Lang RM, Garcia-Fernandez MA, Lodato J, Sugeng L, Lopez J, Knight BP, Messika-Zeitoun D, Shah S, Slater J, Brochet E, Varkey M, Hijazi Z, Marino N, Ruiz C, Kronzon I. Use of real time three-dimensional transesophageal echocardiography in intracardiac catheter based interventions. J Am Soc Echocardiogr. 2009 Aug;22(8):865-82. doi: 10.1016/j.echo.2009.04.031.
PubMed 19647156Faletra FF, Pedrazzini G, Pasotti E, Muzzarelli S, Dequarti MC, Murzilli R, Schlossbauer SA, Slater IP, Moccetti T. 3D TEE during catheter-based interventions. JACC Cardiovasc Imaging. 2014 Mar;7(3):292-308. doi: 10.1016/j.jcmg.2013.10.012.
PubMed 24651102Anter E, Silverstein J, Tschabrunn CM, Shvilkin A, Haffajee CI, Zimetbaum PJ, Buxton AE, Josephson ME, Gelfand E, Manning WJ. Comparison of intracardiac echocardiography and transesophageal echocardiography for imaging of the right and left atrial appendages. Heart Rhythm. 2014 Nov;11(11):1890-7. doi: 10.1016/j.hrthm.2014.07.015. Epub 2014 Jul 14.
PubMed 25034183Rigatelli G, Dell'Avvocata F, Giordan M, Viceconte N, Osanna RA, Braggion G, Aggio S, Cardaioli P, Chen JP. Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry. J Clin Ultrasound. 2014 Nov-Dec;42(9):534-43. doi: 10.1002/jcu.22177. Epub 2014 Jun 4.
PubMed 24898198Medford BA, Taggart NW, Cabalka AK, Cetta F, Reeder GS, Hagler DJ, Johnson JN. Intracardiac echocardiography during atrial septal defect and patent foramen ovale device closure in pediatric and adolescent patients. J Am Soc Echocardiogr. 2014 Sep;27(9):984-90. doi: 10.1016/j.echo.2014.05.017. Epub 2014 Jul 4.
PubMed 24998516Kabra R, Singh J. Recent trends in imaging for atrial fibrillation ablation. Indian Pacing Electrophysiol J. 2010 May 5;10(5):215-27.
PubMed 20473373Lee W, Griffin W, Wildes D, Buckley D, Topka T, Chodakauskas T, Langer M, Calisti S, Bergstol S, Malacrida JP, Lanteri F, Maffre J, McDaniel B, Shivkumar K, Cummings J, Callans D, Silvestry F, Packer D. A 10-Fr ultrasound catheter with integrated micromotor for 4-D intracardiac echocardiography. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jul;58(7):1478-91. doi: 10.1109/TUFFC.2011.1967.
PubMed 21768032Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.
PubMed 24930123Alkhouli M, Chaker Z, Alqahtani F, Raslan S, Raybuck B. Outcomes of Routine Intracardiac Echocardiography to Guide Left Atrial Appendage Occlusion. JACC Clin Electrophysiol. 2020 Apr;6(4):393-400. doi: 10.1016/j.jacep.2019.11.014. Epub 2020 Jan 29.
PubMed 32327072Flautt T, Da-Wariboko A, Lador A, Patel A, Guevara M, Valderrabano M. Left Atrial Appendage Occlusion Without Fluoroscopy: Optimization by 4D Intracardiac Echocardiography. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1592-1594. doi: 10.1016/j.jcin.2022.05.008. No abstract available.
PubMed 35926926Kim SS, Hijazi ZM, Lang RM, Knight BP. The use of intracardiac echocardiography and other intracardiac imaging tools to guide noncoronary cardiac interventions. J Am Coll Cardiol. 2009 Jun 9;53(23):2117-28. doi: 10.1016/j.jacc.2009.01.071.
PubMed 19497437Bartel T, Muller S, Biviano A, Hahn RT. Why is intracardiac echocardiography helpful? Benefits, costs, and how to learn. Eur Heart J. 2014 Jan;35(2):69-76. doi: 10.1093/eurheartj/eht411. Epub 2013 Oct 21.
PubMed 24144789Gianni C, Sanchez JE, Della Rocca DG, Al-Ahmad A, Horton RP, Di Biase L, Natale A. Intracardiac Echocardiography to Guide Catheter Ablation of Atrial Fibrillation. Card Electrophysiol Clin. 2021 Jun;13(2):303-311. doi: 10.1016/j.ccep.2021.03.009. Epub 2021 Apr 23.
PubMed 33990269D. Fornell, "First-in-Human Experience With Novel 4D ICE Catheter For Catheter Ablation and LAA Closure Procedures," 05 Aug 2021. [Online]. Available: https://www.dicardiology.com/content/first-human-experience-novel-4d-ice-catheter-catheter-ablation-and-laa-closure-procedures. [Accessed 18 Oct 2022].
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15. No abstract available.
PubMed 29021841
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
- ClinicalTrials.gov ID
- NCT05970120
- Acronym / sponsor ID
- BWI202104
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Premature Ventricular Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the performance and safety of using the investigational catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUVISION NAV Ultrasound Catheter | Experimental | Device: NUVISION NAV Ultrasound CatheterParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUVISION NAV Ultrasound CatheterParticipants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure. | Device | NUVISION NAV Ultrasound Catheter |
Primary outcome
Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
Time frame: At Day 1
Percentage of participants with completion of imaging with the NUVISION NAV ultrasound catheter without resort to non-study mapping catheter were reported.
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
Time frame: From day of index procedure (Day 1) up to 7 days
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.
5 secondary outcomes
Physician Assessment of Deployment, Maneuverability and Navigational Features With the NUVISION NAV Ultrasound Catheter During the Study Procedures
Time frame: Day 1
Physician Assessment of Imaging Quality Acquired With the NUVISION NAV Ultrasound Catheter During the Study Procedures
Time frame: Day 1
Physicians Overall Feedback on the NUVISION NAV Ultrasound Catheter During the Study Procedures
Time frame: Day 1
Number of Serious Adverse Events (SAEs) Excluding NUVISION NAV Ultrasound Catheter Related SAE Within 7 Days of Index Procedure
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
Time frame: From day of index procedure (Day 1) up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19647156Perk G, Lang RM, Garcia-Fernandez MA, Lodato J, Sugeng L, Lopez J, Knight BP, Messika-Zeitoun D, Shah S, Slater J, Brochet E, Varkey M, Hijazi Z, Marino N, Ruiz C, Kronzon I. Use of real time three-dimensional transesophageal echocardiography in intracardiac catheter based interventions. J Am Soc Echocardiogr. 2009 Aug;22(8):865-82. doi: 10.1016/j.echo.2009.04.031.
- Background: PubMed 24651102Faletra FF, Pedrazzini G, Pasotti E, Muzzarelli S, Dequarti MC, Murzilli R, Schlossbauer SA, Slater IP, Moccetti T. 3D TEE during catheter-based interventions. JACC Cardiovasc Imaging. 2014 Mar;7(3):292-308. doi: 10.1016/j.jcmg.2013.10.012.
- Background: PubMed 25034183Anter E, Silverstein J, Tschabrunn CM, Shvilkin A, Haffajee CI, Zimetbaum PJ, Buxton AE, Josephson ME, Gelfand E, Manning WJ. Comparison of intracardiac echocardiography and transesophageal echocardiography for imaging of the right and left atrial appendages. Heart Rhythm. 2014 Nov;11(11):1890-7. doi: 10.1016/j.hrthm.2014.07.015. Epub 2014 Jul 14.
- Background: PubMed 24898198Rigatelli G, Dell'Avvocata F, Giordan M, Viceconte N, Osanna RA, Braggion G, Aggio S, Cardaioli P, Chen JP. Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry. J Clin Ultrasound. 2014 Nov-Dec;42(9):534-43. doi: 10.1002/jcu.22177. Epub 2014 Jun 4.
- Background: PubMed 24998516Medford BA, Taggart NW, Cabalka AK, Cetta F, Reeder GS, Hagler DJ, Johnson JN. Intracardiac echocardiography during atrial septal defect and patent foramen ovale device closure in pediatric and adolescent patients. J Am Soc Echocardiogr. 2014 Sep;27(9):984-90. doi: 10.1016/j.echo.2014.05.017. Epub 2014 Jul 4.
- Background: PubMed 20473373Kabra R, Singh J. Recent trends in imaging for atrial fibrillation ablation. Indian Pacing Electrophysiol J. 2010 May 5;10(5):215-27.
- Background: PubMed 21768032Lee W, Griffin W, Wildes D, Buckley D, Topka T, Chodakauskas T, Langer M, Calisti S, Bergstol S, Malacrida JP, Lanteri F, Maffre J, McDaniel B, Shivkumar K, Cummings J, Callans D, Silvestry F, Packer D. A 10-Fr ultrasound catheter with integrated micromotor for 4-D intracardiac echocardiography. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jul;58(7):1478-91. doi: 10.1109/TUFFC.2011.1967.
- Background: PubMed 24930123Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.
- Background: PubMed 32327072Alkhouli M, Chaker Z, Alqahtani F, Raslan S, Raybuck B. Outcomes of Routine Intracardiac Echocardiography to Guide Left Atrial Appendage Occlusion. JACC Clin Electrophysiol. 2020 Apr;6(4):393-400. doi: 10.1016/j.jacep.2019.11.014. Epub 2020 Jan 29.
- Background: PubMed 35926926Flautt T, Da-Wariboko A, Lador A, Patel A, Guevara M, Valderrabano M. Left Atrial Appendage Occlusion Without Fluoroscopy: Optimization by 4D Intracardiac Echocardiography. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1592-1594. doi: 10.1016/j.jcin.2022.05.008. No abstract available.
- Background: PubMed 19497437Kim SS, Hijazi ZM, Lang RM, Knight BP. The use of intracardiac echocardiography and other intracardiac imaging tools to guide noncoronary cardiac interventions. J Am Coll Cardiol. 2009 Jun 9;53(23):2117-28. doi: 10.1016/j.jacc.2009.01.071.
- Background: PubMed 24144789Bartel T, Muller S, Biviano A, Hahn RT. Why is intracardiac echocardiography helpful? Benefits, costs, and how to learn. Eur Heart J. 2014 Jan;35(2):69-76. doi: 10.1093/eurheartj/eht411. Epub 2013 Oct 21.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biosense Webster, Inc Clinical Trial study director
Biosense Webster, Inc.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUVISION NAV Ultrasound Catheter in people with Scar-related Atrial Tachycardia and Persistent Atrial Fibrillation, run by Biosense Webster, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Croatia, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Completion of Imaging With the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter (time frame: At Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05970120, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.