Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-10 @ 8:40 PM
Study NCT ID:
NCT03377751
Status:
TERMINATED
Last Update Posted:
2020-09-09
First Post:
2017-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Majority of enrolled patients have withdrawn.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-05', 'studyFirstSubmitDate': '2017-12-09', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom rate of any atrial tachy-arrhythmia during 1 year after ablation procedure', 'timeFrame': 'Within 1 year after the ablation procedure', 'description': 'Any recurrence of ECG or Holter documented atrial tachyarrhythmia\\*\n\n\\* Sustained AF or atrial tachycardia \\>30 s duration.'}], 'secondaryOutcomes': [{'measure': 'Procedure related complication rate', 'timeFrame': 'during procedure and follow-up period(up to 1 year)', 'description': 'any adverse events'}, {'measure': 'Total procedural time', 'timeFrame': 'During procedure', 'description': 'total cumulative amount of radiation exposure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catheter ablation', 'Atrial fibrillation', 'Low voltage area'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '16194689', 'type': 'BACKGROUND', 'citation': 'Nattel S, Shiroshita-Takeshita A, Brundel BJ, Rivard L. Mechanisms of atrial fibrillation: lessons from animal models. Prog Cardiovasc Dis. 2005 Jul-Aug;48(1):9-28. doi: 10.1016/j.pcad.2005.06.002.'}, {'pmid': '16260634', 'type': 'BACKGROUND', 'citation': 'Reant P, Lafitte S, Jais P, Serri K, Weerasooriya R, Hocini M, Pillois X, Clementy J, Haissaguerre M, Roudaut R. Reverse remodeling of the left cardiac chambers after catheter ablation after 1 year in a series of patients with isolated atrial fibrillation. Circulation. 2005 Nov 8;112(19):2896-903. doi: 10.1161/CIRCULATIONAHA.104.523928. Epub 2005 Oct 31.'}, {'pmid': '8813255', 'type': 'BACKGROUND', 'citation': 'Cox JL, Schuessler RB, Lappas DG, Boineau JP. An 8 1/2-year clinical experience with surgery for atrial fibrillation. Ann Surg. 1996 Sep;224(3):267-73; discussion 273-5. doi: 10.1097/00000658-199609000-00003.'}, {'pmid': '18362429', 'type': 'BACKGROUND', 'citation': 'Miyazaki S, Kuwahara T, Takahashi A, Kobori A, Takahashi Y, Nozato T, Hikita H, Sato A, Aonuma K, Hirao K, Isobe M. Effect of left atrial ablation on the quality of life in patients with atrial fibrillation. Circ J. 2008 Apr;72(4):582-7. doi: 10.1253/circj.72.582.'}, {'pmid': '16214831', 'type': 'BACKGROUND', 'citation': 'Stabile G, Bertaglia E, Senatore G, De Simone A, Zoppo F, Donnici G, Turco P, Pascotto P, Fazzari M, Vitale DF. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study). Eur Heart J. 2006 Jan;27(2):216-21. doi: 10.1093/eurheartj/ehi583. Epub 2005 Oct 7.'}, {'pmid': '25053659', 'type': 'BACKGROUND', 'citation': 'Haegeli LM, Calkins H. Catheter ablation of atrial fibrillation: an update. Eur Heart J. 2014 Sep 21;35(36):2454-9. doi: 10.1093/eurheartj/ehu291. Epub 2014 Jul 22.'}, {'pmid': '19084800', 'type': 'BACKGROUND', 'citation': 'Elayi CS, Verma A, Di Biase L, Ching CK, Patel D, Barrett C, Martin D, Rong B, Fahmy TS, Khaykin Y, Hongo R, Hao S, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Potenza D, Fanelli R, Massaro R, Arruda M, Schweikert RA, Natale A. Ablation for longstanding permanent atrial fibrillation: results from a randomized study comparing three different strategies. Heart Rhythm. 2008 Dec;5(12):1658-64. doi: 10.1016/j.hrthm.2008.09.016. Epub 2008 Sep 17.'}, {'pmid': '20606120', 'type': 'BACKGROUND', 'citation': 'Di Biase L, Burkhardt JD, Mohanty P, Sanchez J, Mohanty S, Horton R, Gallinghouse GJ, Bailey SM, Zagrodzky JD, Santangeli P, Hao S, Hongo R, Beheiry S, Themistoclakis S, Bonso A, Rossillo A, Corrado A, Raviele A, Al-Ahmad A, Wang P, Cummings JE, Schweikert RA, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Lewis WR, Natale A. Left atrial appendage: an underrecognized trigger site of atrial fibrillation. Circulation. 2010 Jul 13;122(2):109-18. doi: 10.1161/CIRCULATIONAHA.109.928903. Epub 2010 Jul 6.'}, {'pmid': '21397045', 'type': 'BACKGROUND', 'citation': 'Hayward RM, Upadhyay GA, Mela T, Ellinor PT, Barrett CD, Heist EK, Verma A, Choudhry NK, Singh JP. Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. Heart Rhythm. 2011 Jul;8(7):994-1000. doi: 10.1016/j.hrthm.2011.02.033. Epub 2011 Mar 10.'}, {'pmid': '25946280', 'type': 'BACKGROUND', 'citation': 'Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.'}, {'pmid': '25535691', 'type': 'BACKGROUND', 'citation': 'Kim JS, Shin SY, Na JO, Choi CU, Kim SH, Kim JW, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Does isolation of the left atrial posterior wall improve clinical outcomes after radiofrequency catheter ablation for persistent atrial fibrillation?: A prospective randomized clinical trial. Int J Cardiol. 2015 Feb 15;181:277-83. doi: 10.1016/j.ijcard.2014.12.035. Epub 2014 Dec 11.'}, {'pmid': '24315152', 'type': 'BACKGROUND', 'citation': 'Han SW, Shin SY, Im SI, Na JO, Choi CU, Kim SH, Kim JW, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Does the amount of atrial mass reduction improve clinical outcomes after radiofrequency catheter ablation for long-standing persistent atrial fibrillation? Comparison between linear ablation and defragmentation. Int J Cardiol. 2014 Jan 15;171(1):37-43. doi: 10.1016/j.ijcard.2013.11.041. Epub 2013 Nov 23.'}, {'pmid': '21354332', 'type': 'BACKGROUND', 'citation': 'Gibson DN, Di Biase L, Mohanty P, Patel JD, Bai R, Sanchez J, Burkhardt JD, Heywood JT, Johnson AD, Rubenson DS, Horton R, Gallinghouse GJ, Beheiry S, Curtis GP, Cohen DN, Lee MY, Smith MR, Gopinath D, Lewis WR, Natale A. Stiff left atrial syndrome after catheter ablation for atrial fibrillation: clinical characterization, prevalence, and predictors. Heart Rhythm. 2011 Sep;8(9):1364-71. doi: 10.1016/j.hrthm.2011.02.026. Epub 2011 Feb 23.'}, {'pmid': '24083885', 'type': 'BACKGROUND', 'citation': 'Wu SH, Jiang WF, Gu J, Zhao L, Wang YL, Liu YG, Zhou L, Gu JN, Xu K, Liu X. Benefits and risks of additional ablation of complex fractionated atrial electrograms for patients with atrial fibrillation: a systematic review and meta-analysis. Int J Cardiol. 2013 Oct 25;169(1):35-43. doi: 10.1016/j.ijcard.2013.08.083. Epub 2013 Sep 7.'}, {'pmid': '27859888', 'type': 'BACKGROUND', 'citation': 'Kim JS, Im SI, Shin SY, Kang JH, Na JO, Choi CU, Kim SH, Kim EJ, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Kim YH, Yong HS, Lim HE. Changes in Left Atrial Transport Function in Patients Who Maintained Sinus Rhythm After Successful Radiofrequency Catheter Ablation for Atrial Fibrillation: A 1-Year Follow-Up Multislice Computed Tomography Study. J Cardiovasc Electrophysiol. 2017 Feb;28(2):167-176. doi: 10.1111/jce.13128. Epub 2016 Dec 15.'}, {'pmid': '23476035', 'type': 'BACKGROUND', 'citation': 'Lim HE, Choi CU, Na JO, Choi JI, Kim SH, Kim JW, Kim EJ, Han SW, Park SW, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Kim YH. Effects of iatrogenic myocardial injury on coronary microvascular function in patients undergoing radiofrequency catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):318-26. doi: 10.1161/CIRCEP.113.000282. Epub 2013 Mar 9.'}, {'pmid': '25151631', 'type': 'BACKGROUND', 'citation': 'Rolf S, Kircher S, Arya A, Eitel C, Sommer P, Richter S, Gaspar T, Bollmann A, Altmann D, Piedra C, Hindricks G, Piorkowski C. Tailored atrial substrate modification based on low-voltage areas in catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol. 2014 Oct;7(5):825-33. doi: 10.1161/CIRCEP.113.001251. Epub 2014 Aug 23.'}, {'pmid': '27957132', 'type': 'BACKGROUND', 'citation': 'Rolf S, Hindricks G, Sommer P, Richter S, Arya A, Bollmann A, Kosiuk J, Koutalas E. Electroanatomical mapping of atrial fibrillation: Review of the current techniques and advances. J Atr Fibrillation. 2014 Dec 31;7(4):1140. doi: 10.4022/jafib.1140. eCollection 2014 Dec.'}, {'pmid': '23725815', 'type': 'BACKGROUND', 'citation': 'Im SI, Shin SY, Na JO, Kim YH, Choi CU, Kim SH, Kim JW, Kim EJ, Han SW, Rha SW, Park CG, Seo HS, Oh DJ, Hwang C, Lim HE. Usefulness of neutrophil/lymphocyte ratio in predicting early recurrence after radiofrequency catheter ablation in patients with atrial fibrillation. Int J Cardiol. 2013 Oct 9;168(4):4398-400. doi: 10.1016/j.ijcard.2013.05.042. Epub 2013 May 28. No abstract available.'}, {'pmid': '27755137', 'type': 'BACKGROUND', 'citation': 'Ha AC, Wijeysundera HC, Birnie DH, Verma A. Real-world outcomes, complications, and cost of catheter-based ablation for atrial fibrillation: an update. Curr Opin Cardiol. 2017 Jan;32(1):47-52. doi: 10.1097/HCO.0000000000000348.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate whether pulmonary vein isolation(PVI) plus stepwise additional ablation approach based on the degree of low voltage area versus PVI only can improve procedure outcome in persistent atrial fibrillation(AF) patients.', 'detailedDescription': 'Catheter ablation of AF is well accepted and widely performing treatment method of AF at present. Pulmonary vein isolation (PVI) which aims to electrical isolation of pulmonary veins is currently the standard therapy for AF. But some researchers proposed additional ablation strategy for persistent AF (PeAF) because abnormal atrial substrate may play a role in these patients.\n\nHowever, there are inconsistent reports regarding a success rate of additional catheter ablation methods other than PVI. Thus, there still is no consensus on which strategy is appropriate in addition to PVI. One of these proposed options is complex fractioned atrial electrograms (CFAE) ablation. A meta-analysis of controlled trials comparing PVI alone versus PVI with CFAE reported that the addition of CFAE ablation results in a statistically significant increase in success rate for PeAF patients. Conversely, a prospective multicenter trial, The Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial Part II (STAR-AF II) trial showed that recurrence rate of AF following catheter ablation treatment was not significantly reduced when either linear ablation or ablation of CFAE was performed in addition to PVI. The investigators have previously reported that posterior wall isolation in addition to PVI plus linear lesions reduced recurrence of AF following catheter ablation compared to PVI only but the long-term success rate were markedly lower in the CFAE-guide ablation in addition PVI plus linear lesions group than in PVI plus linear lesions group among PeAF patients. Although benefit of addition CFAE could be originated from modification of abnormal atrial substrate which is generated by structural and electrical remodeling, this possible benefit could be counterbalanced by increased formation of transmural ablation scar which may result in dysfunction of left atrium and recurrence of atrial tachyarrhythmia. A recent study have showed that extent of myocardial injury by catheter ablation was associated with left atrium functional deterioration in patients with paroxysmal AF and myocardial damage provoked that may contribute to recurrence of AF following catheter ablation.\n\nTherefore, identification of PeAF patients who would benefit from additional ablation and tailored stepwise approach based on the identification may lead to reduction of iatrogenic myocardial injury and optimization of the result for the AF catheter ablation.\n\nRecent data have shown that voltage guided mapping of left atrium is a powerful predictor of AF recurrence after PAI and voltage based ablation strategy showed promising result in terms of tailored approach. But, prospective, randomized clinical studies are needed to compare the result of a voltage-based AF ablation to the result of established strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing first-time catheter ablation for AF.\n* Willing and able to provide informed consent\n* Age greater than or equal to 18 years.\n\nExclusion Criteria:\n\n* Patients who have previously undergone AF ablation\n* Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement\n* Patients with chronic renal impairment with creatinine clearance rate of \\<30 mL/min\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT03377751', 'briefTitle': 'Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation?', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Does VoltagE Guided Additional Ablation Improve Procedural Outcome of Atrial Fibrillation Ablation? (The VEGA-AF Study)', 'orgStudyIdInfo': {'id': 'KUGH17287 (VEGA-AF)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional posterior wall isolation', 'description': 'Operator will perform pulmonary vein isolation (PVI) and additional posterior wall isolation if low voltage area exists more than 10% of the left atrium', 'interventionNames': ['Procedure: Additional posterior wall isolation']}, {'type': 'EXPERIMENTAL', 'label': 'Voltage-guided substrate homogenization', 'description': 'Operator will perform pulmonary vein antrum isolation (PVI) and additional substrate modification based on the degree of low voltage area.', 'interventionNames': ['Procedure: Voltage-guided substrate homogenization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PVI only group', 'description': 'Operator will perform PVI only', 'interventionNames': ['Procedure: PVI only group']}], 'interventions': [{'name': 'Additional posterior wall isolation', 'type': 'PROCEDURE', 'description': 'PVI and additional posterior wall isolation will be performed according to the following protocol which is based on low voltage area.\n\n1. Proportion of low voltage area to area of left atrium body \\<10% : PVI only\n2. Proportion of low voltage area to area of left atrium body ≥10% : PVI + Posterior wall isolation\n\n * Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).', 'armGroupLabels': ['Additional posterior wall isolation']}, {'name': 'Voltage-guided substrate homogenization', 'type': 'PROCEDURE', 'description': 'PVI and additional substrate modification at low voltage areas will be performed according to the following protocol which is based on low voltage area.\n\n1. Proportion of low voltage area to area of left atrium body \\<10% : PVI only\n2. Proportion of low voltage area to area of left atrium body ≥10% : PVI + substrate homogenization at low voltage areas\n\n * Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA).', 'armGroupLabels': ['Voltage-guided substrate homogenization']}, {'name': 'PVI only group', 'type': 'PROCEDURE', 'description': 'PVI will be performed in this arm.', 'armGroupLabels': ['PVI only group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'state': 'Guro-gu', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02841', 'city': 'Seoul', 'state': 'Seongbuk-gu', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14754', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Bucheon Sejong Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'overallOfficials': [{'name': 'Hong Euy Lim, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hong Euy Lim, MD', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}