Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00785902
Status:
WITHDRAWN
Last Update Posted:
2011-02-21
First Post:
2008-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2008-11-03', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.'}, {'measure': 'The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge'}], 'secondaryOutcomes': [{'measure': 'The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months'}, {'measure': 'The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is greater than or equal to 18 years of age\n2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines\n3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:\n\n * Mitral valve repair or replacement\n * Aortic valve repair or replacement\n * Tricuspid valve repair or replacement\n * Coronary Artery Bypass procedures\n4. Subject's Left Ventricular Ejection Fraction ≥ 30%\n5. Subject is able and willing to provide written informed consent and comply with study requirements\n6. Subject has life expectancy of at least 1 year\n\nExclusion Criteria:\n\n1. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted\n2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure\n3. Wolff-Parkinson-White syndrome\n4. Prior cardiac surgery (Redo)\n5. Class IV NYHA heart failure symptoms\n6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit\n7. Documented MI within 6 weeks prior to study enrollment\n8. Need for emergent cardiac surgery (i.e. cardiogenic shock)\n9. Known carotid artery stenosis greater than 80%\n10. LA size greater than or equal to 8 cm\n11. Current diagnosis of active systemic infection\n12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion\n13. Pregnancy or desire to get pregnant within 12-months of the study enrollment\n14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes\n15. Renal failure requiring dialysis or hepatic failure\n16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia\n17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders"}, 'identificationModule': {'nctId': 'NCT00785902', 'acronym': 'A', 'briefTitle': 'AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AtriCure, Inc.'}, 'orgStudyIdInfo': {'id': 'CP2008-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AtriCure Bipolar System', 'type': 'DEVICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}}}}