Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01076361
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2010-02-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medtroniccrmtrials@medtronic.com', 'title': '4968 Clinical Trial Leader', 'organization': 'Medtronic'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Post Implant', 'description': "All reported lead related events were adjudicated by a technical review committee and reconciled with Medtronic's Event Analysis Reporting System.", 'eventGroups': [{'id': 'EG000', 'title': 'Model 4968 Participants', 'description': 'All Model 4968 participants in the analysis cohort', 'otherNumAtRisk': 349, 'otherNumAffected': 0, 'seriousNumAtRisk': 349, 'seriousNumAffected': 30}], 'seriousEvents': [{'term': 'Over-sensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insulation breach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High impedance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead conductor fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to capture/loss of capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Threshold rise, Sudden', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to sense', 'stats': [{'groupId': 'EG000', 'numAtRisk': 349, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Probability of the Model 4968 Lead Based on Lead-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}, {'units': 'leads', 'counts': [{'value': '609', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Model 4968 Lead Survival Probability', 'description': 'Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '95.04'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.', 'description': 'The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.', 'unitOfMeasure': 'percentage of Model 4968 Leads', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'leads', 'denomUnitsSelected': 'Participants', 'populationDescription': '22 Model 4968s (in 21 participants) was not available for analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Model 4968 Leads', 'description': 'A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.', 'groupId': 'FG000', 'numSubjects': '370'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Follow-up data was not available for 21 participants (22 leads)', 'groupId': 'FG000', 'numSubjects': '349'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': '22 leads were excluded from analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'All enrolled patients with at least 1 Model 4968 lead implanted'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Patients', 'description': 'All patients who were enrolled and implanted with a Model 4968 Lead'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': '0 - 12 Years', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}, {'title': '13 - 19 Years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': '20 + Years', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '232', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Race/Ethnicity not collected', 'categories': [{'measurements': [{'value': '345', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Not Reportable per Local Laws/Regulations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'A total of 631 leads were implanted in 370 subjects. 22 leads in 21 patients were not included in the analysis due to missing data. The final number of leads analyzed was 609.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2010-02-24', 'resultsFirstSubmitDate': '2013-06-28', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-24', 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Probability of the Model 4968 Lead Based on Lead-related Complications', 'timeFrame': 'The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.', 'description': 'The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epicardial', 'Pacing Lead'], 'conditions': ['Arrhythmia', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.', 'detailedDescription': 'The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects implanted with a 4968 lead.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board\n* Availability of implant, follow-up, and product-related event data\n* Implanted with a Model 4968 Capsure Epi Lead\n\nExclusion Criteria:\n\n* Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant\n* Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center\n* Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded\n* Subjects with exclusion criteria required by local law"}, 'identificationModule': {'nctId': 'NCT01076361', 'acronym': '4968', 'briefTitle': 'Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study', 'orgStudyIdInfo': {'id': '4968'}}, 'contactsLocationsModule': {'locations': [{'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Bakersville', 'state': 'California', 'country': 'United States'}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'Downey', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'city': 'East Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.46883, 'lon': -122.14108}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Salinas', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.67774, 'lon': -121.6555}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'city': 'Marquette', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 46.54354, 'lon': -87.39542}}, {'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'city': 'Ocean City', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.27762, 'lon': -74.5746}}, {'city': 'Parlin', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.46205, 'lon': -74.3382}}, {'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Linz', 'country': 'Austria', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Hasselt', 'country': 'Belgium', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada'}, {'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Homburg/Saar', 'country': 'Germany'}, {'city': 'Catanzaro', 'country': 'Italy', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Reggio Emilia', 'country': 'Italy', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Udine', 'country': 'Italy', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Belgrade', 'country': 'Serbia and Montenegro'}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Skövde', 'country': 'Sweden', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '4968 Clinical Trial Leader', 'role': 'STUDY_CHAIR', 'affiliation': 'Medtronic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}