Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-26 @ 6:50 AM
Study NCT ID:
NCT01334866
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2011-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kristin.j.lawman@medtronic.com', 'phone': '763-514-9809', 'title': 'Kristin Lawman', 'organization': 'Medtronic, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events reported from treatment through 6-month follow-up.', 'description': 'Adverse events were classified as serious by the PI following ISO 14155 standards.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Procedure Cohort', 'description': '89 Subjects received study treatment', 'otherNumAtRisk': 89, 'otherNumAffected': 46, 'seriousNumAtRisk': 89, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis and Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia and blood loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'Bleeding (2), Bleeding/Oozing (1)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Cardiac Index', 'notes': 'Low cardiac index (2), low cardiac index and central venous pressure (1)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical Blood Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Technical Success (Graft Patency) in a MICS Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}, {'units': 'Grafts', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Coronary Artery Bypass Grafting', 'description': '89 Subjects received study treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of procedure (day 1)', 'description': "For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.", 'unitOfMeasure': 'percentage of grafts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Grafts', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Procedural Success in a MICS Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Procedure Cohort', 'description': '89 Subjects received study treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of procedure (day 1)', 'description': 'A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patency of the Index Graft at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}, {'units': 'Grafts', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Coronary Artery Bypass Grafting', 'description': '91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.'}], 'classes': [{'title': 'Grade A', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Grade B', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Grade O', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-procedure', 'description': "For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.\n\nThe FitzGibbon Scoring system is as follows:\n\nA:Excellent graft with unimpaired runoff (\\< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to \\<50% of the grafted coronary artery.\n\nO:Occluded (100% stenosed)", 'unitOfMeasure': 'percentage of grafts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Grafts', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Composite Major Adverse Event Rate (Early)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Coronary Artery Bypass Grafting', 'description': '89 Subjects received study treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)', 'description': 'During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:\n\n* Major hemorrhage/bleeding requiring surgical intervention\n* Aortic complications\n* Graft vessel revision (GVR)\n* Transient ischemic attacks (TIA)\n* Cerebrovascular accidents (CVA)/stroke\n* Myocardial infarction (MI)\n* Death', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite Major Adverse Event Rate (Late)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Minimally Invasive Coronary Artery Bypass Grafting', 'description': '89 Subjects received study treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation', 'description': 'Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:\n\n* Major hemorrhage/bleeding requiring surgical intervention\n* Aortic complications\n* Graft vessel revision (GVR)\n* Transient ischemic attacks (TIA)\n* Cerebrovascular accidents (CVA)/stroke\n* Myocardial infarction (MI)\n* Death', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Minimally Invasive Coronary Artery Bypass Grafting', 'description': '91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '91 subjects were enrolled in the study; with 89 subjects receiving the study treatment.', 'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'medically necessary prior to procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'medically necessary post-procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 91 subjects were enrolled, with 89 subjects receiving the study treatment. The first subject was enrolled on December 30, 2009 and the last subject was enrolled on October 4, 2012. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Completion Cohort', 'description': '91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-03', 'studyFirstSubmitDate': '2011-04-05', 'resultsFirstSubmitDate': '2013-08-09', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-03', 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success (Graft Patency) in a MICS Approach', 'timeFrame': 'At time of procedure (day 1)', 'description': "For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete."}, {'measure': 'Procedural Success in a MICS Approach', 'timeFrame': 'At time of procedure (day 1)', 'description': 'A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.'}, {'measure': 'Patency of the Index Graft at 6 Months', 'timeFrame': '6 months post-procedure', 'description': "For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.\n\nThe FitzGibbon Scoring system is as follows:\n\nA:Excellent graft with unimpaired runoff (\\< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to \\<50% of the grafted coronary artery.\n\nO:Occluded (100% stenosed)"}, {'measure': 'Composite Major Adverse Event Rate (Early)', 'timeFrame': 'During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)', 'description': 'During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:\n\n* Major hemorrhage/bleeding requiring surgical intervention\n* Aortic complications\n* Graft vessel revision (GVR)\n* Transient ischemic attacks (TIA)\n* Cerebrovascular accidents (CVA)/stroke\n* Myocardial infarction (MI)\n* Death'}], 'secondaryOutcomes': [{'measure': 'Composite Major Adverse Event Rate (Late)', 'timeFrame': 'After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation', 'description': 'Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:\n\n* Major hemorrhage/bleeding requiring surgical intervention\n* Aortic complications\n* Graft vessel revision (GVR)\n* Transient ischemic attacks (TIA)\n* Cerebrovascular accidents (CVA)/stroke\n* Myocardial infarction (MI)\n* Death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Minimally invasive coronary surgery', 'Coronary artery bypass grafting', 'MICS CABG'], 'conditions': ['Arteriosclerosis of Coronary Artery Bypass Graft']}, 'referencesModule': {'references': [{'pmid': '24183338', 'type': 'DERIVED', 'citation': 'Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30.'}], 'seeAlsoLinks': [{'url': 'http://www.medtronic.com/', 'label': 'Medtronic, Inc. Corporate Website'}]}, 'descriptionModule': {'briefSummary': 'This clinical study has been developed to evaluate the clinical outcomes in patients undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a minimally invasive coronary bypass procedure that is done on a beating heart via a smaller chest incision, thus avoiding the invasiveness of the standard procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> or equal to 18 and \\< or equal to 80 years of age\n* Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)\n* Left ventricle ejection fraction \\>30%\n* Willing and able to provide written informed consent and comply with study requirements\n\nExclusion Criteria:\n\n* Severe cerebrovascular disease within 90 days of surgery including history of prior stroke.\n* Previous cardiac surgery procedures such as CABG revisions, surgical ablations or valve replacements\n* Congestive heart failure with a New York Heart Association (NYHA) Class IV\n* History of renal insufficiency (i.e. prior serum creatinine of \\>2mg/dl) and/or requiring dialysis\n* Uncontrolled diabetes (i.e. \\>2 serum glucose concentrations of \\>350 mg/dl)\n* Severe uncontrolled systemic hypertension (i.e. systolic pressure \\>160 mmHg)\n* Peripheral/systemic active infection excluding the patient from cardiac surgery\n* Life expectancy of less than 1 year due to other illness such as cancer or pulmonary, hepatic or renal disease\n* Participation in another investigational protocol that may confound the results of this study\n* Female of child bearing potential and lactating or intends to become pregnant during the study\n* Severe distal disease and small posterior lateral targets'}, 'identificationModule': {'nctId': 'NCT01334866', 'acronym': 'MICS', 'briefTitle': 'Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery', 'orgStudyIdInfo': {'id': 'D03782'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Minimally invasive coronary artery bypass graft surgery', 'type': 'PROCEDURE', 'otherNames': ['MICS CABG'], 'description': 'The MICS CABG procedure can bridge the gap between percutaneous coronary intervention (PCI) and standard sternotomy. The key components are direct vision, creating anastomoses with traditional instruments and proximal aortic location.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': 'K1Y4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Joseph McGinn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staten Island University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}