Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-04-15 @ 2:08 PM
Study NCT ID:
NCT01186692
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2010-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Melody® Transcatheter Pulmonary Valve Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.patterson@medtronic.com', 'phone': '763.526.1544', 'title': 'Susan Patterson', 'organization': 'Medtronic'}, 'certainAgreement': {'otherDetails': 'A publication committee is in place for this study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Catheterized Cohort', 'description': 'The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.', 'otherNumAtRisk': 120, 'otherNumAffected': 31, 'seriousNumAtRisk': 120, 'seriousNumAffected': 52}], 'otherEvents': [{'term': 'Pain and discomfort NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Therapeutic and nontherapeutic responses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-site specific procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemias NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematological disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary valvular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rate and rhythm disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmias and cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and vomiting symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhoea (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device issues NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device physical property and chemical issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Therapeutic and nontherapeutic responses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract and lung infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis, bacteraemia, viraemia and fungaemia NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac and vascular procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-site specific procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax and pleural effusions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary thrombotic and embolic conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-site specific embolism and thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted >24 Hours Cohort', 'description': 'The implanted \\>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:\n\n* Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and\n* Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and\n* Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.\n\nThe endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The implanted \\>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Attempted Implant Cohort', 'description': 'The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).'}], 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Procedural success is defined as a composite of the following:\n\n* The TPV is fixated within the desired location, and\n* The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and\n* There is no more than trivial pulmonary regurgitation by angiography\n* The subject is free from explantation of the TPV at 24 hours post-implant', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).'}, {'type': 'SECONDARY', 'title': 'Serious Procedural Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Catheterized Cohort', 'description': 'The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.'}, {'type': 'SECONDARY', 'title': 'Serious Device-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Cohort', 'description': 'The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.'}, {'type': 'SECONDARY', 'title': 'Changes in NYHA Functional Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted > 24 Hours Cohort', 'description': 'The implanted \\>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.'}], 'classes': [{'title': 'Changes in NYHA Functional Classification', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Change in NYHA functional class from pre-implant to 6 month post-implant', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The implanted \\>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable paired NYHA data were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled', 'description': 'All subjects enrolled (n=131)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Not Catheterized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Futher testing contraindicated implant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled Cohort', 'description': 'All subjects enrolled.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2010-08-20', 'resultsFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-31', 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation', 'timeFrame': '6 months', 'description': 'Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:\n\n* Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and\n* Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and\n* Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.\n\nThe endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': '6 Months', 'description': 'Procedural success is defined as a composite of the following:\n\n* The TPV is fixated within the desired location, and\n* The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and\n* There is no more than trivial pulmonary regurgitation by angiography\n* The subject is free from explantation of the TPV at 24 hours post-implant'}, {'measure': 'Serious Procedural Adverse Events', 'timeFrame': '6 Months', 'description': 'A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).'}, {'measure': 'Serious Device-related Adverse Events', 'timeFrame': '6 months', 'description': 'A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).'}, {'measure': 'Changes in NYHA Functional Classification', 'timeFrame': '6 Months', 'description': 'Change in NYHA functional class from pre-implant to 6 month post-implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit']}, 'referencesModule': {'references': [{'pmid': '31419019', 'type': 'DERIVED', 'citation': 'Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.'}, {'pmid': '25459038', 'type': 'DERIVED', 'citation': 'Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17.'}, {'pmid': '23735475', 'type': 'DERIVED', 'citation': 'McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted\n* Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)\n\nExclusion Criteria:\n\n* Implantation in the aortic or mitral position\n* Venous anatomy unable to accommodate a 22-fr size introducer sheath\n* Obstruction of the central veins\n* Clinical or biological signs of infection including active endocarditis\n* Unwilling or unable to provide written informed consent or comply with the follow-up requirements'}, 'identificationModule': {'nctId': 'NCT01186692', 'briefTitle': 'Melody® Transcatheter Pulmonary Valve Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study', 'orgStudyIdInfo': {'id': 'D03909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melody TPV Implant', 'description': 'Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.', 'interventionNames': ['Device: Melody® Transcatheter Pulmonary Valve']}], 'interventions': [{'name': 'Melody® Transcatheter Pulmonary Valve', 'type': 'DEVICE', 'otherNames': ['Melody Transcatheter Pulmonary Valve'], 'description': 'Transcatheter Pulmonary Valve replacement Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.', 'armGroupLabels': ['Melody TPV Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': "Advocate Hope Children's Hospital", 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "CS Mott Children's Hospital, University of Michigan", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15201', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center Dallas, UT Southwestern", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Medical Center, University of Utah", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Jaqueline Kreutzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of University of Pittsburgh Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}