Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-08 @ 5:45 PM
Study NCT ID:
NCT02353351
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055989', 'term': 'Septal Occluder Device'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "The sponsor's study closure justification addressed the 522 Order's questions.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of cardiac erosion', 'timeFrame': '1 year', 'description': 'Cumulative incidence of erosion will be reported as:\n\n• The number of erosions per 8000 subjects.'}], 'secondaryOutcomes': [{'measure': 'Aortic Rim Measurements (< 5 mm, ≥ 5 mm)', 'timeFrame': '1 year'}, {'measure': 'Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)', 'timeFrame': '1 year'}, {'measure': 'Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)', 'timeFrame': '1 year'}, {'measure': 'Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)', 'timeFrame': '1 year'}, {'measure': 'Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)', 'timeFrame': '1 year'}, {'measure': 'Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)', 'timeFrame': '1 year'}, {'measure': 'Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)', 'timeFrame': '1 year'}, {'measure': 'Device Splaying the Aorta (Yes, No)', 'timeFrame': '1 year'}, {'measure': 'Device Impingement of the Aorta (Yes, No)', 'timeFrame': '1 year'}, {'measure': 'Device Abutting the Aorta (Yes, No)', 'timeFrame': '1 year'}, {'measure': 'Age (< 14, ≥ 14 years)', 'timeFrame': '1 year'}, {'measure': 'Gender (Male, Female)', 'timeFrame': '1 year'}, {'measure': 'Device Size Implanted (< 18 mm, ≥ 18 mm)', 'timeFrame': '1 year'}, {'measure': 'Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)', 'timeFrame': '1 year'}, {'measure': 'Body Surface Area (<1.5 m2 and ≥ 1.5m2)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Septal Defect Secundum']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)', 'detailedDescription': 'This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).\n\nThe subject population includes vulnerable patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo participate in this clinical investigation, the patient must meet all of the following inclusion criteria:\n\n1. Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure\n2. Patient is willing and able to complete the follow-up requirements of this study\n3. Patient signs the informed consent (or a legal representative signs the informed consent.)\n\nExclusion Criteria:\n\nPatient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:\n\n1. Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery\n2. Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement\n3. Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)\n4. Patient is known to have a demonstrated intracardiac thrombus on echocardiography\n5. Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization\n6. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein'}, 'identificationModule': {'nctId': 'NCT02353351', 'acronym': 'ASO 522', 'briefTitle': 'ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study', 'orgStudyIdInfo': {'id': 'PS130046'}}, 'armsInterventionsModule': {'interventions': [{'name': 'atrial septal occluder', 'type': 'DEVICE', 'otherNames': ['AMPLATZER Septal Occluder'], 'description': 'Single arm atrial septal defect closure with the AMPLATZER Septal Occluder'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Memorial Hospital', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours/Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Consultants', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Medical Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Arnold Palmer Hospital for Children', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center / Mercy Medical Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sunrise Hospital', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian/Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hospital of New York - Presbyterian", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Holy Spirit Hospital', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '17101', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennslyvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'North Austin Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78411', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': "Driscoll Children's Hospital", 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist DeBakey Heart and Vascular Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital / Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston/Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Medical Research Group', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Ashish Oza', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Devices'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}