Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00841451
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2016-03-23
First Post:
2009-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Vein Isolation Outcomes With Fish Oils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C405603', 'term': 'Omacor'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Persistent', 'Paroxysmal', 'Pulmonary Vein isolation', 'Omega three fatty acids', 'Fish Oils'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test whether pre-treatment with fish oils before catheter ablation of atrial fibrillation decreases the early post operative occurrence of atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Paroxysmal Atrial fibrillation (PAF).\n* Persistent atrial fibrillation. Persistent AF is not self-limited.\n\nExclusion Criteria:\n\n* Previous pulmonary vein isolation ablation procedure\n* Contraindication for anticoagulation\n* Permanent AF\n* Severe valvular pathology\n* Concurrent use of antiarrhythmic medications\n* Inability to give consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00841451', 'acronym': 'PUFA', 'briefTitle': 'Pulmonary Vein Isolation Outcomes With Fish Oils', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's-Roosevelt Hospital Center"}, 'officialTitle': 'Pulmonary Vein Isolation Outcomes With Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid (DHA)', 'orgStudyIdInfo': {'id': '06-123'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lovaza (Fish Oils)', 'type': 'DRUG', 'otherNames': ['Lovaza NDA021654', 'Omacor NDA021853'], 'description': 'Double blinded placebo controlled'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'University Medical Practice Associates 425 West 59th St. #9C', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St.Luke's Hospital 1111 Amsterdam Ave. 3rd Floor Cardiology", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Suneet Mittal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}