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| ID | Type | Description | Link |
|---|---|---|---|
| BWI202104 | Other Identifier | Biosense Webster, Inc. |
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The purpose of this study is to assess the performance and safety of using the investigational catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUVISION NAV Ultrasound Catheter | Device | Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From day of index procedure (Day 1) up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biosense Webster, Inc Clinical Trial | Biosense Webster, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Split | Split | 21000 | Croatia | |||
| Yitzhak Shamir Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19647156 | Background | 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. | |
| 24651102 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2023 | Feb 18, 2025 |
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| 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. | 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. | 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. | 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. | From day of index procedure (Day 1) up to 7 days |
| Ẕerifin |
| 7033001 |
| Israel |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Faletra 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. |
| 25034183 | Background | Anter 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. |
| 24898198 | Background | Rigatelli 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. |
| 24998516 | Background | Medford 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. |
| 20473373 | Background | Kabra R, Singh J. Recent trends in imaging for atrial fibrillation ablation. Indian Pacing Electrophysiol J. 2010 May 5;10(5):215-27. |
| 21768032 | Background | Lee 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. |
| 24930123 | Background | Silvestry 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. |
| 32327072 | Background | Alkhouli 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. |
| 35926926 | Background | Flautt 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. |
| 19497437 | Background | Kim 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. |
| 24144789 | Background | Bartel 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. |
| 33990269 | Background | Gianni 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. |
| Background | D. 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]. |
| 29021841 | Background | 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. |
| 10726030 | Background | Bick RL, Frenkel EP. Clinical aspects of heparin-induced thrombocytopenia and thrombosis and other side effects of heparin therapy. Clin Appl Thromb Hemost. 1999 Oct;5 Suppl 1:S7-15. doi: 10.1177/10760296990050s103. |
| 12751552 | Background | Cox B, Durieux ME, Marcus MA. Toxicity of local anaesthetics. Best Pract Res Clin Anaesthesiol. 2003 Mar;17(1):111-36. doi: 10.1053/bean.2003.0275. |
| 12592301 | Background | Gruchalla RS. 10. Drug allergy. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S548-59. doi: 10.1067/mai.2003.93. |
| 12074414 | Background | Mertes PM, Laxenaire MC. Allergic reactions occurring during anaesthesia. Eur J Anaesthesiol. 2002 Apr;19(4):240-62. doi: 10.1017/s0265021502000418. |
| 11511894 | Background | Morcos SK, Thomsen HS, Webb JA; Contrast Media Safety Committee of the European Society of Urogenital Radiology. Prevention of generalized reactions to contrast media: a consensus report and guidelines. Eur Radiol. 2001;11(9):1720-8. doi: 10.1007/s003300000778. |
| Background | A. C. Lin and D. J. Wilber, Complications Associated With Radiofrequency Catheter Ablation, in Radiofrequency catheter ablation of cardiac arrhythmias: basic concepts and clinical applications, S. H. a. D. Wilber, Ed., Armonk, N.Y.: Futura Publishing Co. Inc., 2000, pp. 737-746 |
| 10879389 | Background | Scheinman MM, Huang S. The 1998 NASPE prospective catheter ablation registry. Pacing Clin Electrophysiol. 2000 Jun;23(6):1020-8. doi: 10.1111/j.1540-8159.2000.tb00891.x. |
| 33476457 | Background | Mar PL, Chong L, Perez A, Lakkireddy D, Gopinathannair R. Entrapment of diagnostic catheter within Advisor HD grid mapping catheter. J Cardiovasc Electrophysiol. 2021 Mar;32(3):860-861. doi: 10.1111/jce.14893. Epub 2021 Jan 28. |
| 19995881 | Background | Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7. |
| 11513440 | Background | Gerstenfeld EP, Guerra P, Sparks PB, Hattori K, Lesh MD. Clinical outcome after radiofrequency catheter ablation of focal atrial fibrillation triggers. J Cardiovasc Electrophysiol. 2001 Aug;12(8):900-8. doi: 10.1046/j.1540-8167.2001.00900.x. |
| 9769307 | Background | Kovoor P, Ricciardello M, Collins L, Uther JB, Ross DL. Risk to patients from radiation associated with radiofrequency ablation for supraventricular tachycardia. Circulation. 1998 Oct 13;98(15):1534-40. doi: 10.1161/01.cir.98.15.1534. |
| 7611155 | Background | Nahass GT. Fluoroscopy and the skin: implications for radiofrequency catheter ablation. Am J Cardiol. 1995 Jul 15;76(3):174-6. doi: 10.1016/s0002-9149(99)80053-8. No abstract available. |
| 1959193 | Background | Calkins H, Niklason L, Sousa J, el-Atassi R, Langberg J, Morady F. Radiation exposure during radiofrequency catheter ablation of accessory atrioventricular connections. Circulation. 1991 Dec;84(6):2376-82. doi: 10.1161/01.cir.84.6.2376. |
| Participants Enrolled With Atrial Arrhythmia |
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| Participants Enrolled With Ventricular Arrhythmia |
|
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 1 |
|
|
| |||||||||||||||||||||||||
| Primary | 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. | Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter. | Posted | Count of Participants | Participants | From day of index procedure (Day 1) up to 7 days |
| ||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Full Range | Score on a scale | Day 1 |
| |||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Full Range | Score on a scale | Day 1 |
| |||||||||||||||||||||||||||
| Secondary | 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. | PP analysis set: all enrolled participants who met study eligibility criteria and in whom assessments were performed with NUVISION NAV ultrasound catheter. Here, 'n' (number analyzed) refers to number of participants analyzed for specified categories. | Posted | Median | Full Range | Score on a scale | Day 1 |
| |||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter. | Posted | Number | SAEs | From day of index procedure (Day 1) up to 7 days |
| ||||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set consisted of all enrolled participants who had undergone insertion of the NUVISION NAV ultrasound catheter. | Posted | Count of Participants | Participants | From day of index procedure (Day 1) up to 7 days |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 30 | 2 | 30 | 2 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complete Atrioventricular block | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Delayed Wound Healing | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Medical Affairs | Biosense Webster, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2024 | Feb 18, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D005117 | Cardiac Complexes, Premature |
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