Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT06352060
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2024-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': 'dlakkireddy@gmail.com', 'phone': '913-934-4300', 'title': 'Dhanunjaya Lakkireddy', 'organization': 'Kansas City Heart Rhythm Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.', 'description': 'All-Cause Mortality events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With ICM', 'description': 'Patients who underwent ICM insertion\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 0, 'otherNumAffected': 2, 'seriousNumAtRisk': 299, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 0, 'otherNumAffected': 9, 'seriousNumAtRisk': 299, 'deathsNumAffected': 0, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Stroke/TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major bleeding episodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'AF-related hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HF-related hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 299, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Freedom From AF, OAC and AAD Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ICM', 'description': 'Patients who underwent ICM insertion\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}, {'id': 'OG001', 'title': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}], 'classes': [{'title': 'Number of patients with freedom from AF', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with freedom from OAC use', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with freedom from AAD use', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.', 'description': 'Number of patients with freedom from AF, OAC and AAD Use after 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes in Participants With ICM and Non-ICM Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ICM', 'description': 'Patients who underwent ICM insertion\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}, {'id': 'OG001', 'title': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}], 'classes': [{'title': 'Access to EP', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'Attempted Rhythm Control With AAD', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}]}, {'title': 'OAC Compliance', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}, {'title': 'Initial Ablation', 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.', 'description': 'Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total CV-related Hospital Stay Duration, Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ICM', 'description': 'Patients who underwent ICM insertion\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}, {'id': 'OG001', 'title': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With ICM', 'description': 'Patients who underwent ICM insertion\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}, {'id': 'FG001', 'title': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '299'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '299'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '598 patients, with 299 in the non-ICM and ICM groups, respectively were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With ICM', 'description': 'Patients who underwent ICM insertion\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}, {'id': 'BG001', 'title': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods\n\nNo intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '72.3', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '72.3', 'spread': '10.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucacian', 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Parosysmal Atrial Fibrillation', 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Persistent Atrial Fibrillation', 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline AAD Use', 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stroke / TIA', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Compensated heart failure (EF <35%)', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary artery disease', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-09', 'size': 256302, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-18T16:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 598}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-02-29', 'resultsFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-01', 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Freedom From AF, OAC and AAD Use', 'timeFrame': '12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.', 'description': 'Number of patients with freedom from AF, OAC and AAD Use after 12 months'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcomes in Participants With ICM and Non-ICM Participants', 'timeFrame': '12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.', 'description': 'Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months'}, {'measure': 'Total CV-related Hospital Stay Duration, Days', 'timeFrame': '12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '14715182', 'type': 'BACKGROUND', 'citation': 'Israel CW, Gronefeld G, Ehrlich JR, Li YG, Hohnloser SH. Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. 2004 Jan 7;43(1):47-52. doi: 10.1016/j.jacc.2003.08.027.'}, {'pmid': '31862084', 'type': 'BACKGROUND', 'citation': 'Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Elkind MSV, Ziegler PD, Kaplon RE, Sherfesee L, Wachter R; REVEAL AF Investigators. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020 Jan;219:128-136. doi: 10.1016/j.ahj.2019.07.016.'}, {'pmid': '34469766', 'type': 'BACKGROUND', 'citation': 'Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.'}, {'pmid': '28842973', 'type': 'BACKGROUND', 'citation': 'Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.'}]}, 'descriptionModule': {'briefSummary': 'Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units.', 'detailedDescription': 'Even with its increasing popularity and use, the impact of ICMs on AF (atrial fibrillation) management is still being determined and can even be conflicting. Furthermore, the use of ICM is dependent on physician preference. It is hypothesized that dynamic monitoring with ICMs is superior to conventional methods and should be used for all patients with AF. Thus, it aimed to measure the outcomes of using ICM versus more traditional approaches in patients with AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with atrial fibrillation management either with ICM or routine management', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients \\> 18 years of age\n* Present for management of AF\n* ICM is inserted at the discretion of the treating physician\n\nExclusion Criteria\n\n* Patients \\< 18 years of age\n* Presence of a permanent pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy\n* Unable to tolerate ICM or traditional monitoring with ECG, Holter, or MCOT monitoring\n* Unable to tolerate AAD, OAC, and CA as part of AF standard of care\n* ICM inserted for cryptogenic stroke or syncope\n* Was not followed \\> 12 months\n* CA performed for AF before ICM implant'}, 'identificationModule': {'nctId': 'NCT06352060', 'briefTitle': 'Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study', 'organization': {'class': 'OTHER', 'fullName': 'Kansas City Heart Rhythm Research Foundation'}, 'officialTitle': 'Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study', 'orgStudyIdInfo': {'id': 'KCHRRF_MONITOR AF_030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with ICM', 'description': 'Patients who underwent ICM insertion', 'interventionNames': ['Other: No intervention or administration will be performed due to the observational nature of the study']}, {'label': 'Non-ICM Participants', 'description': 'Patients with traditional monitoring methods', 'interventionNames': ['Other: No intervention or administration will be performed due to the observational nature of the study']}], 'interventions': [{'name': 'No intervention or administration will be performed due to the observational nature of the study', 'type': 'OTHER', 'description': 'Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.', 'armGroupLabels': ['Non-ICM Participants', 'Participants with ICM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Menorah Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Heart Rhythm Institute - Roe Clinic', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Overland Park Regional Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '64057', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Centerpoint Medical Center Clinic', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '64057', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Centerpoint Medical Center', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '64032', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center Clinic', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64032', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Dhanunjaya Lakkireddy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas City Heart Rhythm Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas City Heart Rhythm Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}