Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
NCT ID: NCT04055740
Last Updated: 2024-09-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2019-09-13
2021-10-31
Brief Summary
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Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IVUS imaging
IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA
IVUS Imaging
IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.
Interventions
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IVUS Imaging
IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.
Eligibility Criteria
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Inclusion Criteria
* Patients with at least one lead over 1 year dwell time requiring extraction
Exclusion Criteria
* Venous occlusion to the extent that the IVUS catheter cannot pass
* Leads \< 1 year dwell time requiring extraction
21 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Hemal Nayak, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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The University of Chicago
Chicago, Illinois, United States
Countries
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References
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Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.
Mond HG, Irwin M, Ector H, Proclemer A. The world survey of cardiac pacing and cardioverter-defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol. 2008 Sep;31(9):1202-12. doi: 10.1111/j.1540-8159.2008.01164.x.
Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.
Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.
Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, Sabik JF, Lindsay BD, Wilkoff BL, Tarakji KG. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. 2014 Mar;11(3):419-25. doi: 10.1016/j.hrthm.2013.12.004. Epub 2013 Dec 4.
Bracke F. Complications and lead extraction in cardiac pacing and defibrillation. Neth Heart J. 2008 Oct;16(Suppl 1):S28-31.
Mazzone P, Tsiachris D, Marzi A, Ciconte G, Paglino G, Sora N, Sala S, Vergara P, Gulletta S, Della Bella P. Predictors of advanced lead extraction based on a systematic stepwise approach: results from a high volume center. Pacing Clin Electrophysiol. 2013 Jul;36(7):837-44. doi: 10.1111/pace.12119. Epub 2013 Mar 19.
Maytin M, Epstein LM, John RM. Lead implant duration does not always predict ease of extraction: extraction sheath may be required at < 1 year. Pacing Clin Electrophysiol. 2011 Dec;34(12):1615-20. doi: 10.1111/j.1540-8159.2011.03225.x. Epub 2011 Oct 20.
Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343.
Bongiorni MG, Di Cori A, Soldati E, Zucchelli G, Arena G, Segreti L, De Lucia R, Marzilli M. Intracardiac echocardiography in patients with pacing and defibrillating leads: a feasibility study. Echocardiography. 2008 Jul;25(6):632-8. doi: 10.1111/j.1540-8175.2008.00656.x.
Sadek MM, Cooper JM, Frankel DS, Santangeli P, Epstein AE, Marchlinski FE, Schaller RD. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm. 2017 Dec;14(12):1779-1785. doi: 10.1016/j.hrthm.2017.08.023. Epub 2017 Aug 24.
Santoshi RKN, Lakhanpal S, Satwah V, Lakhanpal G, Malone M, Pappas PJ. Iliac vein stenosis is an underdiagnosed cause of pelvic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):202-211. doi: 10.1016/j.jvsv.2017.09.007. Epub 2017 Dec 29.
Ganguli S, Hawkins BM, Abtahian F, Abu-Fadel MS, Walker TG, MacKay C, Jaff MR, Weinberg I. Comparison of Inferior Vena Cava Filters Placed at the Bedside via Intravenous Ultrasound Guidance Versus Fluoroscopic Guidance. Ann Vasc Surg. 2017 Feb;39:250-255. doi: 10.1016/j.avsg.2016.06.013. Epub 2016 Aug 28.
Kassavin DS, Constantinopoulos G. The transition to IVUS-guided IVC filter deployment in the nontrauma patient. Vasc Endovascular Surg. 2011 Feb;45(2):142-5. doi: 10.1177/1538574410393753. Epub 2011 Jan 28.
Jeyabalan G, Wallace JR, Chaer RA, Leers SA, Marone LK, Makaroun MS. Endovascular strategies for treatment of embolizing thoracoabdominal aortic lesions. J Vasc Surg. 2014 May;59(5):1256-64. doi: 10.1016/j.jvs.2013.11.068. Epub 2014 Jan 14.
Di Valentino M, Alerci M, Bogen M, Tutta P, Sartori F, Marty B, von Segesser L, Gallino A. Telementoring during endovascular treatment of abdominal aortic aneurysms: a prospective study. J Endovasc Ther. 2005 Apr;12(2):200-5. doi: 10.1583/04-1421.1.
Kolluri R, Fowler B, Ansel G, Silver M. A novel duplex finding of superficial epigastric vein flow reversal to diagnose iliocaval occlusion. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):358-362. doi: 10.1016/j.jvsv.2017.01.017.
Lewis RK, Pokorney SD, Greenfield RA, Hranitzky PM, Hegland DD, Schroder JN, Lin SS, Milano C, Daubert JP, Smith PK, Hurwitz LM, Piccini JP. Preprocedural ECG-gated computed tomography for prevention of complications during lead extraction. Pacing Clin Electrophysiol. 2014 Oct;37(10):1297-305. doi: 10.1111/pace.12485. Epub 2014 Sep 8.
Biefer HR, Hurlimann D, Grunenfelder J, Salzberg SP, Steffel J, Falk V, Starck CT. Generator pocket adhesions of cardiac leads: classification and correlation with transvenous lead extraction results. Pacing Clin Electrophysiol. 2013 Sep;36(9):1111-6. doi: 10.1111/pace.12184. Epub 2013 May 28.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB18-1600
Identifier Type: -
Identifier Source: org_study_id
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