Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 12:59 AM
Study NCT ID:
NCT00355056
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2006-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PREMIUM Migraine Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aoza@sjm.com', 'phone': '818-493-3648', 'title': 'Director, Global Clinical Affairs', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were collected from the time of signing informed consent until the 12-month follow-up visit. After the 12-month follow-up visit, serious adverse events and/or device-related events were collected until completion of study requirements.', 'eventGroups': [{'id': 'EG000', 'title': 'PFO Device Closure', 'description': 'PFO device Closure procedure using the AMPLATZER PFO Occluder device.', 'otherNumAtRisk': 123, 'otherNumAffected': 119, 'seriousNumAtRisk': 123, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sham Procedure', 'description': 'Did not receive the closure device, and treated with the current standard of care medical treatment.', 'otherNumAtRisk': 107, 'otherNumAffected': 103, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Optional PFO Closure', 'description': 'Subjects randomized to the sham arm and completed their 12-month follow up visit were given the option of PFO closure with the Amplatzer PFO Occluder.', 'otherNumAtRisk': 87, 'otherNumAffected': 68, 'seriousNumAtRisk': 87, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Arterial Hypertension/Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fatigue/Generalized Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Common cold/Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 39, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders'}, {'term': 'Vascular Access Site Complication Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders'}, {'term': 'Bruise/Purpura Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'Viral Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Low Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Vascular Access Site Complication Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders'}, {'term': 'Vascular Access Site Complication Bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Mid-Sternal Chest Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vascular Access Site Complication Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Transient atrial fibrillation after device placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Did not receive the closure device, and treated with the current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'PFO device Closure procedure using the AMPLATZER PFO Occluder device.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and months 10-12', 'description': 'A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the analysis were followed for 1-year, had Clinical Event Committee (CEC) adjudicated headache diaries, had greater than or equal to 60% diary compliance during the treatment phase (10-12 months) and were not treatment failures.'}, {'type': 'PRIMARY', 'title': 'Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Device Closure', 'description': 'PFO device Closure procedure using the AMPLATZER PFO Occluder device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '2.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 12 months', 'description': 'Number of subjects who experience a device-related major adverse event (DRMAE) through 12-months of follow-up.\n\nThis endpoint was analyzed using an as-treated cohort that consists of all enrolled subjects who received the device (randomized and Optional PFO Closure group) and who had follow-up sufficient to adequately assess the DRMAE rate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects who received the device (randomized and Optional PFO Closure group). 5 subjects were considered to have insufficient follow-up and were therefore excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Migraine Days/Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and months 10-12', 'description': 'Change in the number of migraine days is calculated by the difference in the mean number of migraine days between the baseline assessment period and the treatment phase (months 10-12 post-procedure) for the respective randomization groups.', 'unitOfMeasure': 'Migraine days per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Successful PFO Closure at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Closure', 'description': 'Device group subjects who had a Core Lab adjudicated TCD grade at Valsalva of less than or equal to 2 at 12-months.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and month 12', 'description': 'Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade \\<= 2', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '117 device subjects completed the 12 month visit. Only 104 had TCDs that were able to be adjudicated. Of the 13 device subjects with unadjudicated TCDs, 4 did not have valsalva data and 9 did not have TCD data available for various reasons.'}, {'type': 'SECONDARY', 'title': 'Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device'}], 'classes': [{'categories': [{'measurements': [{'value': '-17', 'spread': '36', 'groupId': 'OG000'}, {'value': '-22.6', 'spread': '32.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The MIDAS questionnaire measure the impact of headaches on daily living. A total score of 0-5 equals little to no disability, 6-10 equals mild disability, 11-20 equals moderate disability, and a score 21 or greater equals severe disability. The maximum possible score is 276.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '101 participants in the sham group and 116 subjects in the PFO device closure group had both baseline and 12-month MIDAS scores available to perform the analysis.'}, {'type': 'SECONDARY', 'title': 'Incidence of a 75% Reduction in Migraine Headache Attacks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were included in the analysis were followed for 1-year, have CEC adjudicated headache diaries, had greater than or equal to 60% diary compliance during the treatment phase (10-12 months) and were not treatment failures.'}, {'type': 'SECONDARY', 'title': 'Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Closure', 'description': 'Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '88.6', 'upperLimit': '97.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Procedural success is calculated by the percent of device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.'}, {'type': 'SECONDARY', 'title': 'Long-Term Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Closure', 'description': 'Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '87.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year. 117 device subjects completed the 12 month visit. Only 104 had TCDs that were able to be adjudicated.'}, {'type': 'SECONDARY', 'title': 'Incidence of All Adverse Events at 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced an adverse event at or before 12-months post-procedure'}, {'type': 'SECONDARY', 'title': 'Incidence of Device-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Closure', 'description': 'Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '40.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced a device-related adverse event, as adjudicated by the Data Safety and Monitoring Board (DSMB), at or before 12-months post-procedure.'}, {'type': 'SECONDARY', 'title': 'Incidence of a 95% Reduction in Migraine Headache Attacks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000'}, {'value': '8.55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12-months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Beck Depression Inventory (BDI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}, {'id': 'OG001', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The difference in BDI between baseline and 12-months for the respective randomization groups. The highest possible score of the BDI is 63, which represents extreme depression. The lowest possible score is 0, which represents no depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '101 participants in the sham group and 116 subjects in the PFO device closure group had both baseline and 12-month BDI scores available to perform the analysis.'}, {'type': 'POST_HOC', 'title': 'Responder Rate for Subjects in Whom Majority of Attacks Were With Aura', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The term "majority" in "majority of migraine attacks included aura" was defined by the Neurologist (\\>50%) at the time of randomization based on a review of the subject\'s study baseline headache diary and medical history.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Percentage of Subjects With Migraine With Aura Determined to Have a Complete Cessation of Migraine Attacks According to the International Headache Society (IHS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PFO Device Closure', 'description': 'Patients in this arm received the AMPLATZER PFO Occluder device.'}, {'id': 'OG001', 'title': 'Sham Procedure', 'description': 'Sham Procedure and treated only with current standard of care medical treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through months 10-12', 'description': 'Complete Cessation of Migraine Attacks, baseline diary compared to months 10-12', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': '6 PFO Device Closure Subjects and 3 Sham Procedure Subjects with Aura do not have 12-month follow-up data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Procedure', 'description': 'Did not receive the closure device, and treated with the current standard of care medical treatment.'}, {'id': 'FG001', 'title': 'Patent Foramen Ovale (PFO) Device Closure', 'description': 'Patent foramen ovale (PFO) device Closure procedure using the AMPLATZER PFO Occluder device.'}], 'periods': [{'title': 'Randomization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Early Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Optional Patent Foramen Ovale Closure', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A sham procedure was not part of this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who completed Sham Procedure randomization Arm were eligible. 87/103 consented.', 'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '60 day baseline diary completion prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Procedure', 'description': 'Participants will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure).'}, {'id': 'BG001', 'title': 'PFO Device Closure', 'description': 'Participants will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.72', 'spread': '10.16', 'groupId': 'BG000'}, {'value': '42.75', 'spread': '10.27', 'groupId': 'BG001'}, {'value': '43.20', 'spread': '10.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'International Classification of Headache Disorders (ICH)', 'classes': [{'title': 'Migraine with Aura (ICH)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'Migraine without Aura (ICH)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}, {'title': 'Migraine with and without Aura', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants can have more than one International Classification of Headache Disorder, which is why the sum of the three categories exceeds the overall number of baseline participants.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2006-07-19', 'resultsFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-14', 'studyFirstPostDateStruct': {'date': '2006-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Beck Depression Inventory (BDI) Scale', 'timeFrame': '12 months', 'description': 'The difference in BDI between baseline and 12-months for the respective randomization groups. The highest possible score of the BDI is 63, which represents extreme depression. The lowest possible score is 0, which represents no depression.'}], 'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.', 'timeFrame': 'Baseline and months 10-12', 'description': 'A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).'}, {'measure': 'Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)', 'timeFrame': 'Baseline through 12 months', 'description': 'Number of subjects who experience a device-related major adverse event (DRMAE) through 12-months of follow-up.\n\nThis endpoint was analyzed using an as-treated cohort that consists of all enrolled subjects who received the device (randomized and Optional PFO Closure group) and who had follow-up sufficient to adequately assess the DRMAE rate.'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Migraine Days/Month', 'timeFrame': 'Baseline and months 10-12', 'description': 'Change in the number of migraine days is calculated by the difference in the mean number of migraine days between the baseline assessment period and the treatment phase (months 10-12 post-procedure) for the respective randomization groups.'}, {'measure': 'Percentage of Subjects With Successful PFO Closure at 12-months', 'timeFrame': 'Baseline and month 12', 'description': 'Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade \\<= 2'}, {'measure': 'Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months', 'timeFrame': '12 months', 'description': 'The MIDAS questionnaire measure the impact of headaches on daily living. A total score of 0-5 equals little to no disability, 6-10 equals mild disability, 11-20 equals moderate disability, and a score 21 or greater equals severe disability. The maximum possible score is 276.'}, {'measure': 'Incidence of a 75% Reduction in Migraine Headache Attacks', 'timeFrame': '12 months'}, {'measure': 'Procedural Success', 'timeFrame': '12 months', 'description': 'Procedural success is calculated by the percent of device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.'}, {'measure': 'Long-Term Success', 'timeFrame': '12 months', 'description': 'Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year.'}, {'measure': 'Incidence of All Adverse Events at 12-months', 'timeFrame': '12 months'}, {'measure': 'Incidence of Device-related Adverse Events', 'timeFrame': '12 months'}, {'measure': 'Incidence of a 95% Reduction in Migraine Headache Attacks', 'timeFrame': '12-months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Migraine', 'PFO', 'Migraine Headache', 'patent foramen ovale'], 'conditions': ['Migraine Headaches', 'Patent Foramen Ovale']}, 'referencesModule': {'references': [{'pmid': '29191325', 'type': 'DERIVED', 'citation': 'Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, Gurley JC. Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial. J Am Coll Cardiol. 2017 Dec 5;70(22):2766-2774. doi: 10.1016/j.jacc.2017.09.1105.'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.', 'detailedDescription': 'The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed as having migraine headaches both with and without aura\n* Have a Patent Foramen Ovale (PFO)\n* A migraine history and show a refractoriness to medical treatment\n* Willing to participate in follow-up visits\n\nExclusion Criteria:\n\n* Subjects whose primary headaches are other than migraine headaches\n* Who overuse migraine treatments\n* With a clinical history of stroke or Transient Ischemic Attack (TIA)\n* With contraindication to aspirin therapy and Clopidogrel\n* Pregnant or desire to become pregnant within the next year'}, 'identificationModule': {'nctId': 'NCT00355056', 'briefTitle': 'PREMIUM Migraine Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.', 'orgStudyIdInfo': {'id': 'AGA-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Medical Management', 'description': 'Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure).', 'interventionNames': ['Other: Sham Procedure']}, {'type': 'EXPERIMENTAL', 'label': 'PFO Closure', 'description': 'Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.', 'interventionNames': ['Device: AMPLATZER PFO Occluder']}], 'interventions': [{'name': 'Sham Procedure', 'type': 'OTHER', 'description': 'Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.', 'armGroupLabels': ['Medical Management']}, {'name': 'AMPLATZER PFO Occluder', 'type': 'DEVICE', 'description': 'Patients in this arm will receive the AMPLATZER PFO Occluder device', 'armGroupLabels': ['PFO Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital & Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Medical Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '52240', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70124', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '56303', 'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Cloud Hospital', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Johns's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alegent Health Bergan Mercy Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Children's Heart Center Las Vegas", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Mercy Hospital of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14642-8679', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical School', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '17104', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Hospitals', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Healthcare Services', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Sherman Sorensen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Medical Center'}, {'name': 'Stephen Silberstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}, {'name': 'Jonathan Tobis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Andrew Charles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}