Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-28 @ 6:29 PM
Study NCT ID:
NCT00589992
Status:
UNKNOWN
Last Update Posted:
2012-01-31
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibutilide Administration During Pulmonary Vein Ablation
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': 'C067192', 'term': 'ibutilide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-27', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To discern the basic mechanism of Afib by studying its response to Ibutilide administration.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'To compare the ibutilide response in patients with paroxysmal versus permanent Afib', 'timeFrame': 'one year'}, {'measure': 'To study the subgroup of patients that converted to sinus rhythm in order to identify various factors that may have increased their susceptibility to ibutilide.', 'timeFrame': 'one year'}, {'measure': 'To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Pulmonary Vein Ablation']}, 'descriptionModule': {'briefSummary': 'To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients to be scheduled for atrial fibrillation radio frequency ablation\n* paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment\n* symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion\n* patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone\n\nExclusion Criteria:\n\n* patients with recent major hemorrhage (within 6 months)\n* patients with a coagulopathy\n* patients who are pregnant or breast feeding\n* patients with acute congestive heart failure\n* patients with hypokalemia or hyperkalemia\n* patients with a prolonged QTc \\> 440mms\n* patients with polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I\n* patients with left ventricular dysfunction \\< 40%\n* patients with a history of recent MI (\\< 1 month)\n* patients with a history of an angioplasty of \\< 1 month\n* patients with a history of coronary artery bypass grafting surgery of \\< 3 months.\n* patients with a history of chronic renal failure or a creatinine clearance of \\< 30ml/m\n* patients with a history of stroke of \\< 6 months'}, 'identificationModule': {'nctId': 'NCT00589992', 'acronym': 'IBAD-AFIB', 'briefTitle': 'Ibutilide Administration During Pulmonary Vein Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Ball Memorial Hospital'}, 'officialTitle': 'Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.', 'orgStudyIdInfo': {'id': 'BMH study #762'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ibutilide fumarate', 'type': 'DRUG', 'description': 'During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47303', 'city': 'Muncie', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherry Adair, RN', 'role': 'CONTACT', 'email': 'skadair@medicalconsultantspc.com', 'phone': '765-254-4761'}, {'name': 'Antonio Navarrete, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Consultants, P.C.', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}], 'centralContacts': [{'name': 'Antonio Navarrete, MD', 'role': 'CONTACT', 'email': 'annavarr@mac.com', 'phone': '765-281-2000'}, {'name': 'Sherry Adair, RN', 'role': 'CONTACT', 'email': 'skadair@medicalconsultantspc.com', 'phone': '765-254-4761'}], 'overallOfficials': [{'name': 'Antonio Navarrete, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff Physician, Ball Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ball Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Antonio Navarrete, MD', 'oldOrganization': 'Medical Consultants, P.C.'}}}}