Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT00294060
Status:
TERMINATED
Last Update Posted:
2011-05-06
First Post:
2006-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
P3: Pacemaker Patient Profiling Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'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', 'phone': '800-328-2518', 'title': 'P3 Study Team', 'organization': 'Medtronic CRDM'}, 'certainAgreement': {'otherDetails': 'In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic\'s review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Characterization of objectives also encompassed 8 device features (Capture Management, MVP, APP, ARS, PMOP, Rate Response, Mode Switch, Sinus Preference) and 10 additional clinical outcomes. More information is available through the point of contact.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not collected in the P3 Study. The products used in the study are market approved and were used within the indications for use as indicated in the product labeling.', 'description': 'Centers were instructed to report Unanticipated Adverse Device Events (UADE) in the same manner as required for any commercially available device, that is, through the Medical Device Reporting (MDR) processes and in accordance with any reporting requirements required by their IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Pacing Patients', 'description': 'Patients implanted with a pacemaker.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dual Chamber Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2013', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing Patients', 'description': 'Patients implanted with a pacemaker.'}], 'classes': [{'categories': [{'measurements': [{'value': '1684', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at original implant', 'description': 'Pacemaker device choice characterized by the number of patients with dual chamber devices', 'unitOfMeasure': 'Participants with dual chamber devices', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Days Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing Patients', 'description': 'Patients implanted with a pacemaker.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.054', 'spread': '2.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'implant to one year', 'description': 'Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year', 'unitOfMeasure': 'average days hospitalized', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a twelve-month follow-up visit were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Multiple In-clinic Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1459', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pacing Patients', 'description': 'Patients implanted with a pacemaker.'}], 'classes': [{'categories': [{'measurements': [{'value': '768', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'implant to one year', 'description': 'Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation', 'unitOfMeasure': 'participants with 2 or more visits', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pacing Patients', 'description': 'Patients implanted with a pacemaker.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2013'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '840'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1173'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '225'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '797'}]}, {'type': 'Medical condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Device explanted/not replaced', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'Patients were enrolled in the study from March 2004 through April 2006.', 'preAssignmentDetails': 'Only patients who received an approved study device were enrolled in the registry.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2013', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pacing Patients', 'description': 'Patients implanted with a pacemaker.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '266', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1747', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '996', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1017', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2013', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2013}}, 'statusModule': {'whyStopped': 'Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-06', 'studyFirstSubmitDate': '2006-02-16', 'resultsFirstSubmitDate': '2009-07-01', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-06', 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dual Chamber Devices', 'timeFrame': 'at original implant', 'description': 'Pacemaker device choice characterized by the number of patients with dual chamber devices'}, {'measure': 'Days Hospitalized', 'timeFrame': 'implant to one year', 'description': 'Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year'}, {'measure': 'Multiple In-clinic Visits', 'timeFrame': 'implant to one year', 'description': 'Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pacemaker', 'Bradycardia'], 'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets Class I / Class II indications for pacing\n* Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System\n\nExclusion Criteria:\n\n* Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming\n* Patient whose life expectancy is less than two years'}, 'identificationModule': {'nctId': 'NCT00294060', 'briefTitle': 'P3: Pacemaker Patient Profiling Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Pacemaker Patient Profiling (P3) Study', 'orgStudyIdInfo': {'id': '244'}}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Prescott', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Aliso Viejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.56504, 'lon': -117.72712}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'city': 'Escondido', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'city': 'Whittier', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Wildomar', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.59891, 'lon': -117.28004}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'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': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'city': 'Hammond', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.58337, 'lon': -87.50004}}, {'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}, {'city': 'Alpena', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 45.06168, 'lon': -83.43275}}, {'city': 'Cleveland', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 33.744, 'lon': -90.72482}}, {'city': 'Moberly', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.41837, 'lon': -92.43824}}, {'city': 'Osage Beach', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.12956, 'lon': -92.65277}}, {'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'city': 'Kearney', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 40.69946, 'lon': -99.08148}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Clifton', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.85843, 'lon': -74.16376}}, {'city': 'Elizabeth', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.66399, 'lon': -74.2107}}, {'city': 'Galloway', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.48788, 'lon': -74.47598}}, {'city': 'Elmira', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.0898, 'lon': -76.80773}}, {'city': 'Huntington', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.86815, 'lon': -73.42568}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'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': 'Cleveland Heights', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.52005, 'lon': -81.55624}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'city': 'Lorain', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.45282, 'lon': -82.18237}}, {'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Wakefield', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.43732, 'lon': -71.50145}}, {'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'city': 'Sumter', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.92044, 'lon': -80.34147}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Humble', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.99883, 'lon': -95.26216}}, {'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'city': 'Victoria', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 28.80527, 'lon': -97.0036}}, {'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}], 'overallOfficials': [{'name': 'Ravi Kanagala, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Franciscan Skemp Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'P3 Study Team', 'oldOrganization': 'Medtronic CRDM'}}}}