Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-04-18 @ 12:01 PM
Study NCT ID:
NCT02697006
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Synchronized Cardiac Assist for Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Anja.Derlet@fmc-ag.com', 'phone': '+49 6172 608 2801', 'title': 'Dr. Anja Derlet-Savoia', 'organization': 'Fresenius MCD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The low resistance puls kit oxygenator was not available at the inception of, nor the duration of the study, and therefore, efforts to demonstrate the physiological effect of ECG-synchronized, primarily diastolic assist cannot be determined by this study.'}}, 'adverseEventsModule': {'timeFrame': 'up to study exit at 30 days post-procedure, an average of 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'High-Risk PCI Group', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 3, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Cardiogenic Shock', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 5, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deterioration in bispectral index', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope/Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower leg ischemia due to arterial clot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Device and Procedure Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Risk PCI Group', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab'}, {'id': 'OG001', 'title': 'Cardiogenic Shock', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Treated With Technical Success of the Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Risk PCI Group', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab'}, {'id': 'OG001', 'title': 'Cardiogenic Shock', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Device Performance Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Risk PCI Group', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab'}, {'id': 'OG001', 'title': 'Cardiogenic Shock', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-Risk PCI Group', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab'}, {'id': 'FG001', 'title': 'Cardiogenic Shock', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High-Risk PCI Group', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of high-risk percutaneous intervention procedures in the catheterization lab'}, {'id': 'BG001', 'title': 'Cardiogenic Shock', 'description': 'Participants requiring ECG-synchronized cardiac assist in the setting of combined heart-lung failure (cardiogenic shock)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-20', 'size': 1896798, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-04T17:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2016-02-22', 'resultsFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-23', 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Device and Procedure Related Serious Adverse Events', 'timeFrame': '30 days', 'description': 'Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.'}, {'measure': 'Number of Participants Treated With Technical Success of the Device', 'timeFrame': '24 hours', 'description': 'Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).'}, {'measure': 'Number of Participants With Device Performance Success', 'timeFrame': '7 days', 'description': 'Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Shock, Cardiogenic', 'High Risk Percutaneous Coronary Interventions']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cardiogenic shock or in high risk percutaneous intervention procedures in the cardiac catheterization lab', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients in cardiogenic shock in the setting of acute myocardial infarction\n\nor\n\nPatients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.\n\nCardiogenic shock is defined as\n\n* Systolic blood pressure \\< 90 mmHg for at least 30 min or\n* Inotropes are needed to maintain blood pressure \\> 90 mmHg or\n* Clinical signs of heart insufficiency with pulmonary congestion or\n* Signs of end organ hypoperfusion with at least one of the following criteria:\n* Altered mental status\n* cold, damp skin or extremities\n* oliguria (≤ 30 mL/h)\n* serum lactate \\> 2.0 mmol/L\n\nWritten consent of the patient or the legal caregiver\n\n\\-\n\nExclusion Criteria:\n\n* Age \\> 85 years\n* Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \\> 10 min\n* Coma with fixed pupils not induced by drugs;\n* Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)\n* Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)\n* Fever (Body temperature \\> 38.0 °C) or other evidence of sepsis\n* Onset of cardiogenic shock \\> 6 h before enrollment;\n* Lactate \\> 22 mmol/L;\n* Massive pulmonary embolism;\n* Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters\n* Previous known aortic regurgitation greater than grade II\n* Contra-indications for anticoagulation\n* Severe hemolysis of any cause\n* Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.'}, 'identificationModule': {'nctId': 'NCT02697006', 'briefTitle': 'Synchronized Cardiac Assist for Cardiogenic Shock', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial', 'orgStudyIdInfo': {'id': 'Protocol 1.1 Version 1.0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'i-cor Synchronized Cardiac Assist Device', 'type': 'DEVICE', 'description': 'The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Kerckhoff Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}], 'overallOfficials': [{'name': 'Christoph Liebetrau, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xenios AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Avania', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}