Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT02324920
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
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': 'daniele.giacopelli@biotronik.com', 'phone': '+39 3491712305', 'title': 'Daniele Giacopelli', 'organization': 'BIOTRONIK Italiy'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'median follow-up period of 14.1 months', 'eventGroups': [{'id': 'EG000', 'title': 'Active Pacing (DDD+CLS)', 'description': 'The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.\n\nDDD-CLS', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 20, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Inactive Pacing (ODO)', 'description': 'The pacemaker will be programmed in ODO mode.\n\nODO', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 39, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Keloid formation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild pocket bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'unspecified pain around the chest/ pocket.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'inappropriate pacing due to undersensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue (mild obstructive sleep apnea syndrome)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Subtalar arthrodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NSTEMI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lead was not properly connected to the pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients With Recurrence of Syncopal Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Pacing (DDD+CLS)', 'description': 'The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.\n\nDDD-CLS'}, {'id': 'OG001', 'title': 'Inactive Pacing (ODO)', 'description': 'The pacemaker will be programmed in ODO mode.\n\nODO'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.46', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Additional models were implemented to control for country and investigational sites effect on primary endpoint.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Recurrence of Pre-syncope or Syncope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Pacing (DDD+CLS)', 'description': 'The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.\n\nDDD-CLS'}, {'id': 'OG001', 'title': 'Inactive Pacing (ODO)', 'description': 'The pacemaker will be programmed in ODO mode.\n\nODO'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.75', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Pacing (DDD+CLS)', 'description': 'The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.\n\nDDD-CLS'}, {'id': 'FG001', 'title': 'Inactive Pacing (ODO)', 'description': 'The pacemaker will be programmed in ODO mode.\n\nODO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Pacing (DDD+CLS)', 'description': 'The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.\n\nDDD-CLS'}, {'id': 'BG001', 'title': 'Inactive Pacing (ODO)', 'description': 'The pacemaker will be programmed in ODO mode.\n\nODO'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '70'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '73'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-20', 'size': 714307, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-25T06:57', 'hasProtocol': True}, {'date': '2019-02-19', 'size': 847607, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-25T06:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2014-12-19', 'resultsFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2014-12-19', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-21', 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients With Recurrence of Syncopal Episode', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Patients With Recurrence of Pre-syncope or Syncope', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Syncope', 'Closed Loop Stimulation', 'CLS'], 'conditions': ['Syncope']}, 'referencesModule': {'references': [{'pmid': '33279955', 'type': 'DERIVED', 'citation': 'Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516. doi: 10.1093/eurheartj/ehaa936.'}, {'pmid': '28472974', 'type': 'DERIVED', 'citation': 'Brignole M, Tomaino M, Aerts A, Ammirati F, Ayala-Paredes FA, Deharo JC, Del Rosso A, Hamdan MH, Lunati M, Moya A, Gargaro A; BIOSync Study Steering Committee. Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial. Trials. 2017 May 4;18(1):208. doi: 10.1186/s13063-017-1941-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients affected by clinical diagnosis of reflex syncope who meet all the following criteria:\n\n* age \\>=40 years\n* significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.\n* type 2B cardio-inhibitory response to TT (according to the VASIS classification).\n* Alternative therapies have failed or were not feasible.\n* exclusion of other possible competitive causes of syncope.\n\nExclusion Criteria:\n\n\\- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines\n\nAny cardiac dysfunctions possibly leading to loss of consciousness:\n\n* overt heart failure;\n* ejection fraction (LVEF) \\<40% (Echo-assessed within 3-month prior to study participation);\n* myocardial infarction;\n* diagnosis of hypertrophic or dilated cardiomyopathy;\n* clinically significant valvular disease;\n* sinus bradycardia \\<50 bpm or sinoatrial block;\n* Mobitz I second-degree atrioventricular block;\n* Mobitz II second or third-degree atrioventricular block;\n* bundle-branch block;\n* rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;\n* preexcited QRS complexes;\n* prolonged QT interval;\n* Brugada syndrome;\n* arrhythmogenic right ventricular cardiomyopathy\n* Symptomatic orthostatic hypotension diagnosed by standing BP measurement;\n* Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).\n* Symptomatic cardioinhibitory carotid sinus hypersensitivity.'}, 'identificationModule': {'nctId': 'NCT02324920', 'acronym': 'BIOSync CLS', 'briefTitle': 'Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.', 'orgStudyIdInfo': {'id': 'BA103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DDD+CLS', 'description': 'The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.', 'interventionNames': ['Device: DDD-CLS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ODO', 'description': 'The pacemaker will be programmed in ODO mode.', 'interventionNames': ['Device: ODO']}], 'interventions': [{'name': 'DDD-CLS', 'type': 'DEVICE', 'armGroupLabels': ['DDD+CLS']}, {'name': 'ODO', 'type': 'DEVICE', 'armGroupLabels': ['ODO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'CHUS Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Aix-en-Provence', 'country': 'France', 'facility': "Pais d'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tricase', 'state': 'BA', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Policlinico Consorziale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bolzano', 'country': 'Italy', 'facility': 'Ospedale Centrale di Bolzano', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': 'A.O. Pugliese-Ciaccio', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': "Azienda Ospedaliera Niguarda Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Orbassano', 'country': 'Italy', 'facility': 'A.O.U. San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'AO di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Casilino', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Ziekenjuis', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Santa Marta', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital De Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebròn", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Santa Cruz', 'country': 'Spain', 'facility': 'Hospital Universitario Nuestra Senora de la Candelaria', 'geoPoint': {'lat': 38.0218, 'lon': -1.05749}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}