Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-01 @ 8:27 AM
Study NCT ID:
NCT03729232
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Catheter Ablation Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2018-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with recurrence of targeted arrhythmia', 'timeFrame': 'Through discharge from hospital, approximately up to 1 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of deaths', 'timeFrame': 'Through discharge from hospital, approximately up to 1 weeks', 'description': 'All-cause death, cardiovascular death, and procedure-related death'}, {'measure': 'Number of patients with treatment-related complications', 'timeFrame': '3 months', 'description': 'Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catheter Ablation', 'Cardiac Arrhythmias', 'Registry', 'Complication', 'REDCap'], 'conditions': ['Catheter Ablation', 'Cardiac Arrhythmias']}, 'referencesModule': {'references': [{'pmid': '40995616', 'type': 'DERIVED', 'citation': 'Matsuda Y, Masuda M, Kanaoka K, Mano T, Inoue K, Yamashita S, Iwasaki YK, Nakamura K, Nagashima K, Miyamoto K, Satomi K, Takatsuki S, Kusano K, Yamane T, Shimizu W. Real-World Outcomes of Repeat Ablation Strategies for Atrial Fibrillation: Insights From the Japanese Catheter Ablation Registry. J Arrhythm. 2025 Sep 22;41(5):e70200. doi: 10.1002/joa3.70200. eCollection 2025 Oct.'}, {'pmid': '40861252', 'type': 'DERIVED', 'citation': 'Goto K, Miyazaki S, Tonegawa-Kuji R, Kanaoka K, Yamashita S, Sasano T, Iwanaga Y, Nakai M, Inoue K, Iwasaki YK, Nagashima K, Nakamura K, Masuda M, Miyamaoto K, Satomi K, Takatsuki S, Kusano K, Yamane T, Shimizu W. Efficacy and Safety of Second Sessions of Catheter Ablation for Idiopathic Premature Ventricular Contractions: From the Nationwide Japan Catheter Ablation Registry. J Arrhythm. 2025 Aug 25;41(4):e70181. doi: 10.1002/joa3.70181. eCollection 2025 Aug.'}, {'pmid': '40714332', 'type': 'DERIVED', 'citation': 'Oikawa J, Fukaya H, Kanaoka K, Niwano S, Miyamoto K, Iwanaga Y, Iwasaki YK, Nagashima K, Masuda M, Yamashita S, Nakamura K, Satomi K, Takatsuki S, Inoue K, Kusano K, Yamane T, Tada H, Shimizu W. Efficacy and safety of catheter ablation for paroxysmal atrial fibrillation: A comparison of first-line vs second-line therapy. Heart Rhythm. 2025 Jul 24:S1547-5271(25)02711-0. doi: 10.1016/j.hrthm.2025.07.030. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Japanese Cather Ablation (J-AB) Registry is a voluntary nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The objectives of this registry are to observe and describe developments in the catheter ablation treatment of arrhythmia in Japan and to provide reliable information on the type of activity performed and the facilities available in Japanese arrhythmia units.', 'detailedDescription': 'Japanese Cather Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center.\n\nThis study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed at every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with catheter ablation in Japan\n\nExclusion Criteria:\n\n* Patients who refused to consent'}, 'identificationModule': {'nctId': 'NCT03729232', 'acronym': 'J-AB', 'briefTitle': 'Japanese Catheter Ablation Registry', 'organization': {'class': 'OTHER', 'fullName': 'National Cerebral and Cardiovascular Center, Japan'}, 'officialTitle': 'Japanese Catheter Ablation Registry', 'orgStudyIdInfo': {'id': 'M28-114'}, 'secondaryIdInfos': [{'id': 'UMIN000028288', 'type': 'OTHER', 'domain': 'UMIN-CTR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '564-8565', 'city': 'Suita', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kengo Kusano, MD, PhD', 'role': 'CONTACT', 'email': 'kusanokengo@ncvc.go.jp', 'phone': '+81-6-6170-1070'}, {'name': 'Misa Takegami, PhD, MPH', 'role': 'CONTACT', 'email': 'takegami@ncvc.go.jp', 'phone': '+81-6-6170-1070'}], 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'centralContacts': [{'name': 'Kengo Kusano, MD, PhD', 'role': 'CONTACT', 'email': 'kusanokengo@ncvc.go.jp', 'phone': '+81-6-6170-1070'}, {'name': 'Misa Takegami, PhD, MPH', 'role': 'CONTACT', 'email': 'takegami@ncvc.go.jp', 'phone': '+81-6-6170-1070'}], 'overallOfficials': [{'name': 'Teiichi Yamane, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Jikei University School of Medicine'}, {'name': 'Kengo Kusano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cerebral and Cardiovascular Center, Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cerebral and Cardiovascular Center, Japan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiovascular Medicine, National Cerebral and Cardiovascular Center', 'investigatorFullName': 'Kengo Kusano', 'investigatorAffiliation': 'National Cerebral and Cardiovascular Center, Japan'}}}}