Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00268320
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2005-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Investigation of the Medtronic Concerto™ Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-22', 'studyFirstSubmitDate': '2005-12-21', 'studyFirstSubmitQcDate': '2005-12-21', 'lastUpdatePostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate'}, {'measure': 'Atrial defibrillation effectiveness'}], 'secondaryOutcomes': [{'measure': 'Change in patient health status during the study'}, {'measure': 'System performance'}, {'measure': 'Adverse events'}]}, 'conditionsModule': {'keywords': ['congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator'], 'conditions': ['Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed.\n\nPeople who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).\n\nAtrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.\n\nThe purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who require the implantation of an Implantable Cardioverter Defibrillator\n* Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)\n* Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)\n\nExclusion Criteria:\n\n* Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)\n* Subjects who are post-heart transplant'}, 'identificationModule': {'nctId': 'NCT00268320', 'briefTitle': 'Clinical Investigation of the Medtronic Concerto™ Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)', 'orgStudyIdInfo': {'id': '230'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'city': 'Linz', 'country': 'Austria', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Sankt Pölten', 'country': 'Austria', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Aachen', 'country': 'Germany', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Bernau', 'country': 'Germany', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'city': 'Bochum', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Göttingen', 'country': 'Germany', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Heidelberg', 'country': 'Germany', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Pátrai', 'country': 'Greece', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Negrar', 'state': 'Veneto', 'country': 'Italy', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'city': 'Bologna', 'country': 'Italy', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Eindhoven', 'country': 'Netherlands', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 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