ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation - ICE Flutter Study
NCT ID: NCT05229848
Last Updated: 2022-02-08
Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-02-28
2022-04-30
Brief Summary
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Detailed Description
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3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL. However, there are instances when ablation of the CTI is challenging as a result of various factors including a thick Eustachian ridge, presence of a sub-Eustachian pouch, or prominent pectinate muscles. Isthmus anatomy has been shown to affect the parameters of ablation procedure. 3D mapping to overcome difficult anatomy may not be the answer for difficult situations as shown by some operators . These anatomical challenges can not only lengthen procedural times but also lead to increased risk of complications such as perforation, effusion, or cardiac tamponade. Intracardiac echocardiography (ICE), has been an essential component of Radiofrequency (RF) ablations for AF given its association with decreased fluoroscopy time and complication rates, and therefore it is logical that this can be applied to CTI ablations for AFL as well. There are however no studies to date that directly focused on the benefits of adding ICE during CTI dependent AFL ablation. Currently it is not required that operators use ICE in every case of AFL ablation. Investigators intend to study the routine use of ICE in such cases and to see if there is a significant benefit in routine use of ICE.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3D electroanatomical mapping alone
Patients who are diagnosed with typical right sided flutter who are scheduled for an ablation procedure will be enrolled. Informed consent will be obtained from each of them prior to the procedure. Patients will be randomly assigned to undergo either 3D electroanatomical mapping alone vs ICE plus 3D electroanatomical mapping guided CTI ablation. Operators will plan to alternate each case with the use of ICE + 3D mapping and 3D mapping alone with one method followed by the other for randomization. All patients will have the standard access sheaths placed in the right femoral vein.
3D electroanatomical mapping alone guided CTI ablation
3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL.
ICE plus 3D electroanatomical mapping
Patients who are diagnosed with typical right sided flutter who are scheduled for an ablation procedure will be enrolled. Informed consent will be obtained from each of them prior to the procedure. Patients will be randomly assigned to undergo either 3D electroanatomical mapping alone vs ICE plus 3D electroanatomical mapping guided CTI ablation. Operators will plan to alternate each case with the use of ICE + 3D mapping and 3D mapping alone with one method followed by the other for randomization. All patients will have the standard access sheaths placed in the right femoral vein. The group randomized to ICE catheter placement will have a left femoral 11F sheath placed in addition.
ICE plus 3D electroanatomical mapping guided CTI ablation
ICE imaging catheter is typically introduced through an 11-F hemostatic sheath and positioned under fluoroscopic guidance in the right atrium. After catheter coupling to the imaging platform, imaging frequency is optimized by the operator using adjunctive gain, depth, and focal length controls to define anatomic structures and minimize noise. Imaging is performed at different levels in the right atrium, if needed. Imaging targets included the right atrium, coronary sinus orifice, fossa ovalis, interatrial septum (IAS), tricuspid valve, left atrium, left atrial appendage, orifice of all pulmonary veins, mitral valve, papillary muscles, aortic and pulmonary valve leaflets, right ventricle, RVOT, pericardial space, esophagus, aorta and adjoining left ventricular and right ventricular myocardium.
Interventions
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3D electroanatomical mapping alone guided CTI ablation
3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL.
ICE plus 3D electroanatomical mapping guided CTI ablation
ICE imaging catheter is typically introduced through an 11-F hemostatic sheath and positioned under fluoroscopic guidance in the right atrium. After catheter coupling to the imaging platform, imaging frequency is optimized by the operator using adjunctive gain, depth, and focal length controls to define anatomic structures and minimize noise. Imaging is performed at different levels in the right atrium, if needed. Imaging targets included the right atrium, coronary sinus orifice, fossa ovalis, interatrial septum (IAS), tricuspid valve, left atrium, left atrial appendage, orifice of all pulmonary veins, mitral valve, papillary muscles, aortic and pulmonary valve leaflets, right ventricle, RVOT, pericardial space, esophagus, aorta and adjoining left ventricular and right ventricular myocardium.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who cannot give an informed consent will be excluded.
* Patients in who vascular access for the 11F sheath is not feasible will be excluded. Those with left iliac vein stenosis or left groin arteriovenous (AV) fistulas or prior left groin access complications will be excluded.
* Patients who on the EP (Electrophysiology) study are found to have a left sided arrhythmia needing transseptal access will be excluded.
* Patients who during EP study are found to have atypical flutter pathways including Left Atrial (LA)/Left sided flutter as above, atypical pathways outside of the CTI, and scar based- reentry pathways.
18 Years
ALL
No
Sponsors
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Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy, MD
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute
Locations
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Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Granada J, Uribe W, Chyou PH, Maassen K, Vierkant R, Smith PN, Hayes J, Eaker E, Vidaillet H. Incidence and predictors of atrial flutter in the general population. J Am Coll Cardiol. 2000 Dec;36(7):2242-6. doi: 10.1016/s0735-1097(00)00982-7.
Halligan SC, Gersh BJ, Brown RD Jr, Rosales AG, Munger TM, Shen WK, Hammill SC, Friedman PA. The natural history of lone atrial flutter. Ann Intern Med. 2004 Feb 17;140(4):265-8. doi: 10.7326/0003-4819-140-4-200402170-00008.
Bun SS, Latcu DG, Marchlinski F, Saoudi N. Atrial flutter: more than just one of a kind. Eur Heart J. 2015 Sep 14;36(35):2356-63. doi: 10.1093/eurheartj/ehv118. Epub 2015 Apr 2.
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
Sehar N, Mears J, Bisco S, Patel S, Lachman N, Asirvatham SJ. Anatomic guidance for ablation: atrial flutter, fibrillation, and outflow tract ventricular tachycardia. Indian Pacing Electrophysiol J. 2010 Aug 10;10(8):339-56.
Da Costa A, Faure E, Thevenin J, Messier M, Bernard S, Abdel K, Robin C, Romeyer C, Isaaz K. Effect of isthmus anatomy and ablation catheter on radiofrequency catheter ablation of the cavotricuspid isthmus. Circulation. 2004 Aug 31;110(9):1030-5. doi: 10.1161/01.CIR.0000139845.40818.75. Epub 2004 Aug 23.
Schernthaner C, Haidinger B, Brandt MC, Kraus J, Danmayr F, Hoppe UC, Strohmer B. The influence of cavotricuspid isthmus length on total radiofrequency energy to cure right atrial flutter. Kardiol Pol. 2016;74(3):237-43. doi: 10.5603/KP.a2015.0159. Epub 2015 Aug 25.
Cohen TJ, Ibrahim B, Lazar J, Rosen J, Klein J. Utility of intracardiac echocardiography (ICE) in electrophysiology: ICEing the CAKE (catheter ablation knowledge enhancement). J Invasive Cardiol. 1999 Jun;11(6):364-8.
Other Identifiers
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KCHRF-ICE Flutter-0010
Identifier Type: -
Identifier Source: org_study_id
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