Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-02 @ 4:23 PM
Study NCT ID:
NCT02138695
Status:
RECRUITING
Last Update Posted:
2019-03-18
First Post:
2014-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical recurrence of atrial fibrillation (AF) after catheter ablation', 'timeFrame': 'Participants will be followed for 5 year after catheter ablation', 'description': 'We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Patients were asked to attend scheduled outpatient follow-up appointments 2, 6, 12, 18, 24, 36, 48 and 60 months after catheter ablation.'}]}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'catheter ablation', 'recurrence'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40974035', 'type': 'DERIVED', 'citation': 'Cho S, Kim D, Park H, Kwon OS, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Mapping and ablation outcomes of extra-pulmonary vein triggers in atrial fibrillation: single-centre retrospective study with consistent provocation protocol. Europace. 2025 Oct 7;27(10):euaf225. doi: 10.1093/europace/euaf225.'}, {'pmid': '39443659', 'type': 'DERIVED', 'citation': 'Hwang T, Lim B, Kwon OS, Kim MH, Kim D, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Hwang C, Pak HN. Clinical usefulness of digital twin guided virtual amiodarone test in patients with atrial fibrillation ablation. NPJ Digit Med. 2024 Oct 23;7(1):297. doi: 10.1038/s41746-024-01298-z.'}, {'pmid': '39189473', 'type': 'DERIVED', 'citation': 'Park JS, Cho I, Kim D, Kim MH, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Differentiating Left Atrial Pressure Responses in Paroxysmal and Persistent Atrial Fibrillation: Implications for Diagnosing Heart Failure With Preserved Ejection Fraction and Managing Atrial Fibrillation. J Am Heart Assoc. 2024 Sep 3;13(17):e035246. doi: 10.1161/JAHA.124.035246. Epub 2024 Aug 27.'}, {'pmid': '38532181', 'type': 'DERIVED', 'citation': 'Jin Z, Hwang T, Kim D, Lim B, Kwon OS, Kim S, Kim MH, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Anti- and pro-fibrillatory effects of pulmonary vein isolation gaps in human atrial fibrillation digital twins. NPJ Digit Med. 2024 Mar 26;7(1):81. doi: 10.1038/s41746-024-01075-y.'}, {'pmid': '35332048', 'type': 'DERIVED', 'citation': 'Park YJ, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Sex difference in atrial fibrillation recurrence after catheter ablation and antiarrhythmic drugs. Heart. 2023 Mar 10;109(7):519-526. doi: 10.1136/heartjnl-2021-320601.'}, {'pmid': '35211517', 'type': 'DERIVED', 'citation': 'Kim M, Yu HT, Kim TH, Lee DI, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN. Ischemic Stroke in Non-Gender-Related CHA2DS2-VA Score 0~1 Is Associated With H2FPEF Score Among the Patients With Atrial Fibrillation. Front Cardiovasc Med. 2022 Feb 8;8:791112. doi: 10.3389/fcvm.2021.791112. eCollection 2021.'}, {'pmid': '35086918', 'type': 'DERIVED', 'citation': 'Kwon OS, Hong M, Kim TH, Hwang I, Shim J, Choi EK, Lim HE, Yu HT, Uhm JS, Joung B, Oh S, Lee MH, Kim YH, Pak HN. Genome-wide association study-based prediction of atrial fibrillation using artificial intelligence. Open Heart. 2022 Jan;9(1):e001898. doi: 10.1136/openhrt-2021-001898.'}, {'pmid': '34414218', 'type': 'DERIVED', 'citation': 'Kim M, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. One-Year Change in the H2FPEF Score After Catheter Ablation of Atrial Fibrillation in Patients With a Normal Left Ventricular Systolic Function. Front Cardiovasc Med. 2021 Aug 3;8:699364. doi: 10.3389/fcvm.2021.699364. eCollection 2021.'}, {'pmid': '33483352', 'type': 'DERIVED', 'citation': 'Pak HN, Park JW, Yang SY, Kim M, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH. Sex differences in mapping and rhythm outcomes of a repeat atrial fibrillation ablation. Heart. 2021 Dec;107(23):1862-1867. doi: 10.1136/heartjnl-2020-318282. Epub 2021 Jan 22.'}, {'pmid': '30917688', 'type': 'DERIVED', 'citation': 'Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Hwang C, Pak HN. Atrial Fibrillation Catheter Ablation Increases the Left Atrial Pressure. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e007073. doi: 10.1161/CIRCEP.118.007073.'}, {'pmid': '26842122', 'type': 'DERIVED', 'citation': 'Kim TH, Lee JS, Park J, Park JK, Uhm JS, Joung B, Lee MH, Pak HN. Blunted rate-dependent left atrial pressure response during isoproterenol infusion in atrial fibrillation patients with impaired left ventricular diastolic function: a comparison to pacing. Europace. 2015 Oct;17 Suppl 2:ii89-96. doi: 10.1093/europace/euv239.'}, {'pmid': '26272656', 'type': 'DERIVED', 'citation': 'Choi EK, Park JH, Lee JY, Nam CM, Hwang MK, Uhm JS, Joung B, Ko YG, Lee MH, Lubitz SA, Ellinor PT, Pak HN. Korean Atrial Fibrillation (AF) Network: Genetic Variants for AF Do Not Predict Ablation Success. J Am Heart Assoc. 2015 Aug 13;4(8):e002046. doi: 10.1161/JAHA.115.002046.'}]}, 'descriptionModule': {'briefSummary': '1\\. Purpose of the study\n\n1\\) To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics.\n\n2\\) To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Scientific evidence of the study\n\n1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.\n2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.\n3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.\n4. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. However, there are few studies concerning these multifactorial variables.\n\n3\\. Study population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei Cardiovascular hospital, Yonsei university health system, Seoul, Korea.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation\n\nExclusion Criteria:\n\n* patients who do not agree with study inclusion\n* permanent AF refractory to electrical cardioversion\n* AF with valvular disease ≥ grade 2\n* patients with left atrial diameter greater than 60mm\n* patients with age less than 19'}, 'identificationModule': {'nctId': 'NCT02138695', 'briefTitle': 'The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Yonsei AF Cohort', 'description': 'Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hui-Nam Pak', 'role': 'CONTACT', 'email': 'hnpak@yuhs.ac', 'phone': '82-2-2228-8459'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hui-Nam Pak, MD', 'role': 'CONTACT', 'email': 'hnpak@yuhs.ac', 'phone': '82-2-2228-8459'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}