Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-29 @ 4:14 PM
Study NCT ID:
NCT03836092
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2019-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECGI in Patients With Persistent Atrial Fibrillation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-09', 'studyFirstSubmitDate': '2019-01-27', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from Atrial Fibrillation', 'timeFrame': '1 year', 'description': 'termination via ablation from atrial fibrillation during follow up period'}], 'secondaryOutcomes': [{'measure': 'termination via ablation from atrial fibrillation during procedure', 'timeFrame': 'over 6 months', 'description': 'Termination of AF to NSR during procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '15172410', 'type': 'RESULT', 'citation': 'Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.'}, {'pmid': '25028391', 'type': 'RESULT', 'citation': 'Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.'}, {'pmid': '29759610', 'type': 'RESULT', 'citation': 'Conti S, 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, Verma A. Effect of Different Cutpoints for Defining Success Post-Catheter Ablation for Persistent Atrial Fibrillation: A Substudy of the STAR AF II Trial. JACC Clin Electrophysiol. 2017 May;3(5):522-523. doi: 10.1016/j.jacep.2016.12.006. Epub 2017 May 15. No abstract available.'}, {'pmid': '27374307', 'type': 'RESULT', 'citation': 'Oketani N, Seitz J, Salazar M, Pisapia A, Kalifa J, Smit JJ, Nademanee K. Ablation of complex fractionated electrograms is useful for catheter ablation of persistent atrial fibrillation: Protagonist point of view. Heart Rhythm. 2016 Oct;13(10):2098-100. doi: 10.1016/j.hrthm.2016.06.036. Epub 2016 Jul 1. No abstract available.'}, {'pmid': '25257091', 'type': 'RESULT', 'citation': 'Nademanee K, Amnueypol M, Lee F, Drew CM, Suwannasri W, Schwab MC, Veerakul G. Benefits and risks of catheter ablation in elderly patients with atrial fibrillation. Heart Rhythm. 2015 Jan;12(1):44-51. doi: 10.1016/j.hrthm.2014.09.049. Epub 2014 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.', 'detailedDescription': 'The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied to determine:\n\n* The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF initiators and AF perpetuators as targets sites for catheter ablations in patients with persistent AF.\n* The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate ablations by targeting complex fractionated atrial electrograms (CFAE).\n* If there is a relationship between primary CFAE sites and driver sites or other distinct patterns from the ECGI mapping system.\n* The rate of AF termination to sinus rhythm after ablation at target sites identified by ECGI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF from 7 days to 12 months and long- lasting AF beyond twelve months.\n* Patients who are symptomatic\n* Patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic\n\nExclusion Criteria:\n\n* Patients under 18 years or over 85 years of age.\n* Patients with chronic alcoholism.\n* Recent myocardial infarction within one month of the study.\n* Significant debilitating diseases or a terminal disease.\n* Patients with documented left atrial thrombus.\n* Medical or mental conditions precluding a long-term follow-up.'}, 'identificationModule': {'nctId': 'NCT03836092', 'briefTitle': 'ECGI in Patients With Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Pacific Rim Electrophysiology Research Institute'}, 'officialTitle': 'Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'PACIFICRERI3'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bumrungrad International Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacific Rim Electrophysiology Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Koonlawee Nademanee, MD', 'investigatorAffiliation': 'Pacific Rim Electrophysiology Research Institute'}}}}