Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-31 @ 3:46 AM
Study NCT ID:
NCT01717469
Status:
UNKNOWN
Last Update Posted:
2012-11-06
First Post:
2012-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-05', 'studyFirstSubmitDate': '2012-09-30', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Participants will be evaluated at 6 and 24 months after PM implantation', 'description': 'Quality of life: improvement on quality of life scores measured by three questionnaires: 36-Item Short Form Health Survey (SF-36), a disease specific questionnaire for pacemaker patients (Aquarel) and Minnesota Living With Heart Failure (MLWHF).'}], 'primaryOutcomes': [{'measure': 'Surgical success', 'timeFrame': 'Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days', 'description': 'Surgical success: absence of complications'}], 'secondaryOutcomes': [{'measure': 'Echocardiographic and Clinical composite', 'timeFrame': 'Participants will be evaluated at 6 and 24 months after PM implantation', 'description': 'Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pacemaker', 'Pacemaker implantation', 'Coronary sinus', 'Ventricular dysfunction', 'Right ventricular pacing', 'Left ventricular pacing'], 'conditions': ['Bradyarrhythmias', 'Arrhythmias', 'Atrioventricular Block', 'Ventricular Dysfunction', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.', 'detailedDescription': 'Over the past several years, there has been growing concern over the significant deleterious effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development of heart failure (HF). However, it remains unclear whether pacing-related ventricular dyssynchrony can translate into significant LV structural changes and produce important clinical impairment in an average pacemaker population with compromised AV conduction. Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony and to improve symptoms and prognosis in patients with mild to moderated systolic HF and prolonged QRS duration.\n\nThis randomized controlled study is been conducted to compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The hypothesis is that isolated LV pacing through the coronary sinus can be used safely and provide greater hemodynamic benefits to patients with AV block and normal ventricular function who require only the correction of heart rate.\n\nSpecifically, the investigator aims are to evaluate the safety, efficacy and the effects of left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model 4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria for conventional pacemaker stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Pacemaker initial implant by transvenous approach\n* Presence of AV block\n* Presence of atrial fibrillation / atrial flutter with slow ventricular response\n* Left ventricular systolic function \\> 0.40\n* Subject agreed to participate and signed the consent form\n\nExclusion Criteria:\n\n* Absence of venous access\n* Impediment of venous access due to presence of intracardiac defects\n* Impediment of venous access due to presence of tricuspid valve prosthesis\n* Need for radiotherapy in the chest\n* Presence of chest deformity\n* Pregnancy\n* Life expectancy of less than one year\n* Contraindication to administration of iodinated contrast (creatinine \\> 3.0) Unable to attend the follow-up appointments'}, 'identificationModule': {'nctId': 'NCT01717469', 'acronym': 'SAFE-LVPACE', 'briefTitle': 'Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias', 'orgStudyIdInfo': {'id': 'CAAE 00610412.2.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RV Pacing', 'description': 'Right ventricular pacing', 'interventionNames': ['Device: Right ventricular pacing (Medtronic)']}, {'type': 'EXPERIMENTAL', 'label': 'LV Pacing', 'description': 'Left ventricular pacing through coronary sinus tributaries', 'interventionNames': ['Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)']}], 'interventions': [{'name': 'Left ventricular pacing through coronary sinus tributaries (Attain StarFix)', 'type': 'DEVICE', 'otherNames': ['Attain StarFix® Model 4195 OTW Lead'], 'description': 'Left ventricular pacing in patients with bradycardia', 'armGroupLabels': ['LV Pacing']}, {'name': 'Right ventricular pacing (Medtronic)', 'type': 'DEVICE', 'otherNames': ['Right ventricular lead Medtronic 5076-58'], 'description': 'Conventional right ventricular pacing in patients with bradycardia.', 'armGroupLabels': ['RV Pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Robeto Costa, MD PhD', 'role': 'CONTACT', 'email': 'rcosta@gmail.com', 'phone': '55-11-2661', 'phoneExt': '5284'}, {'name': 'Katia R Silva, RN PhD', 'role': 'CONTACT', 'email': 'katia.research@gmail.com', 'phone': '9195978619'}, {'name': 'Roberto Costa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elizabeth S Crevelari, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katia R Silva, RN, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caio MM Albertini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marianna S Lacerda, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martino Martinelli Filho, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wagner T Tamaki, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roberto M Oliveira Jr, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wilson Mathias Jr, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Silvana AD Nishioka, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Irapuan M Penteado, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Roberto Costa, MD PhD', 'role': 'CONTACT', 'email': 'rcosta@incor.usp.br', 'phone': '55-11-2661', 'phoneExt': '5284'}, {'name': 'Katia R Silva, RN PhD', 'role': 'CONTACT', 'email': 'katia.research@gmail.com', 'phone': '9195978619'}], 'overallOfficials': [{'name': 'Roberto Costa, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor of Cardiovascular Surgery, MD PhD', 'investigatorFullName': 'Roberto Costa', 'investigatorAffiliation': 'University of Sao Paulo'}}}}