Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT02246803
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2014-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Assessment of Progression of Paroxysmal AF After CABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of atrial fibrillation', 'timeFrame': 'up to 36 months', 'description': 'Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.\n\nAtrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF\\>0.5% were classified as non-responders.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization due to atrial fibrillation after surgery', 'timeFrame': 'Within three years after surgery', 'description': 'All cases of hospitalization due to atrial fibrillation after surgery'}, {'measure': 'Cardiovascular events', 'timeFrame': 'Within three years after surgery', 'description': 'All cases of stroke, cardiac infarction, thromboembolism, bleeding and death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['paroxysmal atrial fibrillation, CABG, pulmonary vein isolation'], 'conditions': ['Paroxysmal Atrial Fibrillation, Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.\n\nHypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.', 'detailedDescription': "This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about pulmonary vein isolation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG\n* At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months\n* The patient's consent to participate in the study\n\nExclusion Criteria:\n\n* Intolerance of antiarrhythmic drugs\n* Heart valve disease requiring invasive treatment\n* Left atria more than 6.5 cm\n* Prior cardiac surgery\n* Active pacemaker treatment\n* Active anti-arrhythmic treatment (AAD) class I and III\n* Contraindication to oral anticoagulant/heparin treatment\n* Ejection fraction less than 30 % (EF \\< 30 %) assessed by transthoracic echocardiography"}, 'identificationModule': {'nctId': 'NCT02246803', 'briefTitle': 'The Assessment of Progression of Paroxysmal AF After CABG', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring', 'orgStudyIdInfo': {'id': 'AF-Progress'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CABG+pulmonary vein isolation', 'description': 'CABG+pulmonary vein isolation procedure', 'interventionNames': ['Procedure: CABG+Pulmonary vein isolation procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isolated CABG', 'description': 'Isolated CABG procedure', 'interventionNames': ['Procedure: Isolated CABG']}], 'interventions': [{'name': 'CABG+Pulmonary vein isolation procedure', 'type': 'PROCEDURE', 'description': 'Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG', 'armGroupLabels': ['CABG+pulmonary vein isolation']}, {'name': 'Isolated CABG', 'type': 'PROCEDURE', 'description': 'Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.', 'armGroupLabels': ['Isolated CABG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Julia Kareva, PhD', 'role': 'CONTACT', 'email': 'julia11108@mail.ru', 'phone': '+79069952839'}], 'facility': 'Meshalkin State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Julia Kareva', 'role': 'CONTACT', 'email': 'julia11108@mail.ru', 'phone': '+79069952839'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Meshalkin Research Institute of Pathology of Circulation', 'investigatorFullName': 'Alexander Romanov', 'investigatorAffiliation': 'Meshalkin Research Institute of Pathology of Circulation'}}}}