Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-21 @ 10:00 PM
Study NCT ID:
NCT01477658
Status:
UNKNOWN
Last Update Posted:
2013-05-07
First Post:
2011-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535758', 'term': 'Congenital heart block'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-04', 'studyFirstSubmitDate': '2011-11-18', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '24 months after enrollment'}], 'secondaryOutcomes': [{'measure': 'Echocardiogram and Clinical Composite', 'timeFrame': 'baseline and 24 months after enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Congenital Complete Atrioventricular Heart Block', 'Pacemaker', 'Cardiac pacing', 'Children', 'Heart failure', 'Ventricular dyssynchrony', 'Echocardiography', 'Quality of life', 'Six-minute walk test', 'Young adults'], 'conditions': ['Congenital Complete Atrioventricular Heart Block', 'High Grade Atrioventricular Block', 'Postoperative Complete Heart Block']}, 'descriptionModule': {'briefSummary': 'Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. The occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (AVB) are still unknown.\n\nThus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.', 'detailedDescription': 'This is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced AVB.\n\nThe design of the study will involve the following stages:\n\n1. Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing;\n2. Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test;\n3. Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);\n4. Follow-up: patients will be monitored during 24 months.\n\nThe main end-points are:\n\n* Clinical and functional changes (NYHA functional class)\n* Heart failure hospitalization\n* Quality of life\n* Overall and cardiac mortality\n* Cardiac resynchronization therapy and heart transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulatory Care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\<18 years at initial pacemaker implantation\n* Advanced AV block with /without congenital heart defects\n* Time under cardiac pacing superior than one year\n* Unicameral or atrioventricular pacing in single right ventricle site\n* Informed consent of the patient or responsible\n\nExclusion Criteria:\n\n* Bifocal or biventricular pacing\n* Discontinuing use of the device for recovery of atrioventricular conduction\n* Cardiac transplantation\n* Inability to participate in the study procedures'}, 'identificationModule': {'nctId': 'NCT01477658', 'briefTitle': 'Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block', 'orgStudyIdInfo': {'id': 'CAPPesq nº 1248/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital AV Block', 'description': 'Patients diagnosed with Congenital Complete Atrioventricular Heart Block'}, {'label': 'Postoperative AV Block', 'description': 'Patients diagnosed with postoperative AV block'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute (InCor) of University of São Paulo Medical School (Brazil)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Roberto Costa, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Roberto M Oliveira Jr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor of Cardiovascular Surgery', 'investigatorFullName': 'Roberto Costa', 'investigatorAffiliation': 'University of Sao Paulo'}}}}