Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-04 @ 7:08 PM
Study NCT ID:
NCT01463358
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.santini@rmnet.it', 'phone': '+390666494491', 'title': 'Massimo Santini MD FESC FACC', 'organization': 'Casa di Cura san Pio XI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'number of subjects with serious and non-serious adverse events of cardiac and non-cardiac origin, with identification of organ cause. Method for systematic assessment: regular investigator assessment at follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 22, 'seriousNumAtRisk': 49, 'deathsNumAffected': 2, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate) DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 20, 'seriousNumAtRisk': 52, 'deathsNumAffected': 2, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'symptomatic Atrial Arrhythmias', 'notes': 'non-serious: not requiring hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'notes': 'non-serious: treated with variation to medical therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pacemaker signal oversensing/undersensing', 'notes': 'non serious: resolved with pacemaker reprogramming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pacemaker: rise in pacing threshold', 'notes': 'non serious: resolved with pacemaker reprogramming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'atrio-ventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'symptomatic bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'symptomatic atrial arrhyhtmias', 'notes': 'serious: requiring hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ventricular arrhyhtmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure exhacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Miocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intervention for coronary artery disease', 'notes': 'Coronary artery Bypass Graft or Percutaneous angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peripheral vascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease (COPD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of pacemaker capture', 'notes': 'requiring invasive system revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacing lead dislodgment', 'notes': 'requiring invasive system revision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker system infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever/virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined Endpoint Defined as First Occurrence Among the Following Events 1)Syncope Episode of Any Origin; 2)Presyncopal Episode With Documented Cardioinhibitory Origin 3) Atrioventricular Block of Any Degree Associated With Patient Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.'}, {'id': 'OG001', 'title': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate)\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of participants experiencing syncope episodes, symptomatic pre-syncopal episodes associated with a device intervention (ventricular pacing) and symptomatic episodes associated with documentation of intermittent or permanent atrio-ventricular block', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.'}, {'id': 'OG001', 'title': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate)\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.'}, {'id': 'OG001', 'title': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate)\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.'}, {'id': 'FG001', 'title': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate)\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.'}, {'id': 'BG001', 'title': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate)\n\nDDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific): pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '8', 'groupId': 'BG000'}, {'value': '77', 'spread': '8', 'groupId': 'BG001'}, {'value': '77', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2011-06-27', 'resultsFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2011-10-28', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-23', 'studyFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined Endpoint Defined as First Occurrence Among the Following Events 1)Syncope Episode of Any Origin; 2)Presyncopal Episode With Documented Cardioinhibitory Origin 3) Atrioventricular Block of Any Degree Associated With Patient Symptoms', 'timeFrame': '2 years', 'description': 'Number of participants experiencing syncope episodes, symptomatic pre-syncopal episodes associated with a device intervention (ventricular pacing) and symptomatic episodes associated with documentation of intermittent or permanent atrio-ventricular block'}], 'secondaryOutcomes': [{'measure': 'Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.', 'timeFrame': '2 years'}, {'measure': 'Atrial Fibrillation', 'timeFrame': '2 years', 'description': 'patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Syncope', 'Bifascicular block', 'Bradycardia pacing'], 'conditions': ['Bifascicular Block', 'Syncope']}, 'referencesModule': {'references': [{'pmid': '24336948', 'type': 'DERIVED', 'citation': 'Brignole M, Donateo P, Tomaino M, Massa R, Iori M, Beiras X, Moya A, Kus T, Deharo JC, Giuli S, Gentili A, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Benefit of pacemaker therapy in patients with presumed neurally mediated syncope and documented asystole is greater when tilt test is negative: an analysis from the third International Study on Syncope of Uncertain Etiology (ISSUE-3). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):10-6. doi: 10.1161/CIRCEP.113.001103. Epub 2013 Dec 12.'}, {'pmid': '23390123', 'type': 'DERIVED', 'citation': 'Santini M, Castro A, Giada F, Ricci R, Inama G, Gaggioli G, Calo L, Orazi S, Viscusi M, Chiodi L, Bartoletti A, Foglia-Manzillo G, Ammirati F, Loricchio ML, Pedrinazzi C, Turreni F, Gasparini G, Accardi F, Raciti G, Raviele A. Prevention of syncope through permanent cardiac pacing in patients with bifascicular block and syncope of unexplained origin: the PRESS study. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):101-7. doi: 10.1161/CIRCEP.112.975102. Epub 2013 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'Study Objective\n\nThe purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.', 'detailedDescription': 'Primary endpoint\n\nFirst occurrence of a composite of Syncope of any origin OR Presyncopal episode with documented cardioinhibitory origin OR Atrioventricular block of any degree; all associated with patient symptoms\n\nDesign:\n\n* Randomized, prospective, single blinded, two parallel arms\n* Treatment group : DDD60 - programmed in DDD mode / 60 lower limit\n* Control Group: DDI30 - programmed in DDI mode / 30 lower limit\n* Randomization type: block randomization: Block size: 4, allocation ratio 1:1\n\nSample: 100 patients\n\nPopulation\n\n* Patients with bifascicular block with at least one syncopal episode within the last 6 months preceding enrollment.\n* Patients should be negative to a series of pre-enrollment screening in order to exclude:\n* Brady-tachy syndrome, vasovagal syncope or carotid sinus syndrome, atrial fibrillation, inducible AV block\n* Ejection fraction \\>=40%\n* Mean nocturnal heart rate \\>=35 bpm'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of Bifascicular block\n* At least one episode of syncope during last 6 months from the enrollment\n\nExclusion Criteria:\n\n* Patients with Brady-tachy syndrome that needs of pacemaker to prevent the symptomatic bradycardia o symptomatic tachycardia arrhythmia\n* Patients with vasovagal syndrome by positive TTT or carotid sinus syndrome\n* Patients with Chronic Atrial Fibrillation\n* Patients with Atrial Ventricular Block induces at EPS'}, 'identificationModule': {'nctId': 'NCT01463358', 'acronym': 'PRESS', 'briefTitle': 'Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block', 'orgStudyIdInfo': {'id': 'GDT-20040601-PRESS-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DDI30', 'description': 'Control group based only on backup pacing with lower rate 30 ppm', 'interventionNames': ['Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DDD60', 'description': 'Treatment arm based on full pacing support (60 Lower Rate)', 'interventionNames': ['Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)']}], 'interventions': [{'name': 'DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)', 'type': 'DEVICE', 'otherNames': ['INSIGNIA® pacing systems Guidant (Boston Scientific)'], 'description': 'pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block', 'armGroupLabels': ['DDD60']}, {'name': 'DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)', 'type': 'DEVICE', 'otherNames': ['INSIGNIA® pacing systems Guidant (Boston Scientific)'], 'description': 'pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.', 'armGroupLabels': ['DDI30']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bagno a Ripoli', 'country': 'Italy', 'facility': 'Ospedale Santa Maria Annunziata', 'geoPoint': {'lat': 43.75115, 'lon': 11.32252}}, {'city': 'Caserta', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Sebastiano', 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'city': 'Como', 'country': 'Italy', 'facility': 'Ospedale Valduce', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Crema', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Osp. Maggiore', 'geoPoint': {'lat': 45.36264, 'lon': 9.68176}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Nuovo Ospedale S. Giovanni di Dio', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale Villa Scassi', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Mestre', 'country': 'Italy', 'facility': 'Ospedale Umberto I', 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Ostia - Roma', 'country': 'Italy', 'facility': 'Ospedale GB Grassi'}, {'city': 'Rieti', 'country': 'Italy', 'facility': 'Ospedale Civile G. De Lellis', 'geoPoint': {'lat': 42.40476, 'lon': 12.85735}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Filippo Neri', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Sandro Pertini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Casilino', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Massimo Santini, MD,FESC,FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Filippo Neri, Roma, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}