A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Ventricular Tachycardia Clinical Trial

Official title:

Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05970120
• Other study ID #: BWI202104
• Secondary ID: BWI202104
• Status: Completed
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the performance and safety of using the investigational catheter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 22, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)

• Signed participants Informed Consent Form (ICF)

• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

• Structural heart defect which can only be repaired by cardiac surgery

• Pericarditis within 6 months

• Left ventricular ejection fraction (LVEF) less than or equal to (<=) 25 percent (%) for ventricular tachycardia (VT) participants

• LVEF <= 40% for participants with atrial arrhythmia

• History of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux

• History of abnormal bleeding and/or clotting disorder

• Clinically significant infection or sepsis

• History of stroke or transient ischemic attack (TIA) within the past 6 months of enrollment

• Uncontrolled heart failure or New York Heart Association (NYHA) function class IV

• Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)

• Implanted with a mechanical valve

• Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation

• Any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention

• Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or significant coagulation disorder)

• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study

• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation

• Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being

• Concurrent enrollment in an investigational study evaluating another device or drug

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation
• Premature Ventricular Complex
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

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.

Locations

Country	Name	City	State
Croatia	KBC Split	Split
Israel	Yitzhak Shamir Medical Center	Zerifin
Italy	Centro Cardiologico Monzino	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Croatia,  Israel,  Italy, 

References & Publications (28)

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

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. — View Citation

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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. — View Citation

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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. — View Citation

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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].

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Completion of Imaging with the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter	Number of participants who have successfully completed the procedure (imaging with the NUVISION NAV ultrasound catheter) without resort to a non-study ultrasound device will be reported.	Up to 5 months
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 will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.	Up to 7 days of index procedure
Secondary	Physician Assessment of Deployment, Maneuverability, Navigational Features and Imaging Quality Acquired with the NUVISION NAV Ultrasound Catheter During the Study Procedures	Physician assessment on deployment, maneuverability, navigational features, and imaging quality acquired with the NUVISION NAV ultrasound catheter will be reported. A post-procedure survey will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.	Up to 5 months
Secondary	Number of Participants with Other SAEs (Excluding NUVISION NAV Ultrasound Catheter Related SAE) Within 7 Days of Index Procedure	Number of Participants with other SAEs (excluding NUVISION NAV ultrasound catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.	Up to 7 days of index procedure
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 will be reported. An adverse event is any untoward medical occurrence in a participant whether or not related to the investigational device.	Up to 7 days of index procedure