Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-26 @ 6:49 PM
Study NCT ID:
NCT01922518
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2013-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Right Ventricular Pacing Determined by Electrocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054537', 'term': 'Atrioventricular Block'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'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': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-21', 'studyFirstSubmitDate': '2013-07-04', 'studyFirstSubmitQcDate': '2013-08-11', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '> 10% decrease of ejection fraction', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrioventricular block, cardiomyopathy'], 'conditions': ['Atrioventricular Block']}, 'referencesModule': {'references': [{'pmid': '25380704', 'type': 'DERIVED', 'citation': 'Kim SH, Oh YS, Nam GB, Choi KJ, Park JS, Park SW, Park SJ, On YK, Kim JS, Shin WS, Kim JH, Jang SW, Lee MY, Kim YH, Rho TH. Paced QRS axis as a predictor of pacing-induced left ventricular dysfunction. J Interv Card Electrophysiol. 2014 Dec;41(3):223-9. doi: 10.1007/s10840-014-9950-7. Epub 2014 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. In conclusion, this study demonstrate that impact of right ventricular pacing determined by electrocardiography was planned.', 'detailedDescription': 'Patients who has Atrioventricular block scheduled for artificial pacemaker Randomized select 1:1 apex beats and ventricular septal beat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Atrioventricular block, pacemaker scheduled\n\nExclusion Criteria:\n\n* History of myocardial infarction\n* Valvular heart disease (grade ≥ 2 )\n* History of Left ventricular dysfunction ( ejection fraction \\<50% or LV dimension \\>60 mm in the pre-procedure echocardiogram)'}, 'identificationModule': {'nctId': 'NCT01922518', 'acronym': 'RVpacing', 'briefTitle': 'Impact of Right Ventricular Pacing Determined by Electrocardiography', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Impact of Right Ventricular Pacing Determined by Electrocardiography; Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'SeoulStMary-RVP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Septal pacing group', 'description': 'Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis', 'interventionNames': ['Procedure: Septal pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apex pacing group', 'description': 'Put RV lead around the apex', 'interventionNames': ['Procedure: Apex pacing']}], 'interventions': [{'name': 'Septal pacing', 'type': 'PROCEDURE', 'description': 'Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis', 'armGroupLabels': ['Septal pacing group']}, {'name': 'Apex pacing', 'type': 'PROCEDURE', 'description': 'Put RV lead around the apex', 'armGroupLabels': ['Apex pacing group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seo Cho Gu', 'country': 'South Korea', 'facility': "Seoul st. mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong seog Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yong Seog Oh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yong Seog Oh', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}