Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-01-23 @ 3:40 PM
Study NCT ID:
NCT01791218
Status:
TERMINATED
Last Update Posted:
2020-09-02
First Post:
2013-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Pulmonary Vein Isolation Efficiency Study
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Not enough patients for study arms', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation burden', 'timeFrame': 'Within one year after operative treatment', 'description': 'Atrial fibrillation burden is defined as the amount of atrial fibrillation on one week Holter monitoring'}, {'measure': 'Freedom of symptomatic and asymptomatic atrial fibrillation after surgery', 'timeFrame': 'Within one year after operative treatment', 'description': 'Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds.\n\nFreedom of atrial fibrillation is defined as duration of atrial fibrillation less than 0,5% of the one week Holter monitoring'}], 'secondaryOutcomes': [{'measure': 'Compare quality of life (QOL) and symptoms, correlation of symptoms with atrial fibrillation', 'timeFrame': 'Within one year after operative treatment'}, {'measure': 'Adverse events after surgery in both arms', 'timeFrame': 'Within one year after operative treatment'}, {'measure': 'Anti-arrhythmic treatment after surgery', 'timeFrame': 'Within one year after treatment'}, {'measure': 'Hospitalization due to atrial fibrillation after surgery', 'timeFrame': 'Within one year after operative treatment'}, {'measure': 'Cardioversion for the treatment of atrial fibrillation after surgery', 'timeFrame': 'Within one year after operative treatment'}, {'measure': 'Other cardiovascular related events: death, stroke, cardiac infarction, need for revascularization and bleeding', 'timeFrame': 'Within one year after operative treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary vein isolation', 'Paroxysmal atrial fibrillation', 'Quality of life'], 'conditions': ['Paroxysmal Atrial Fibrillation', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.\n\nThere is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.'}, '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* Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion\n* written and verbal consent\n\nExclusion Criteria:\n\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\n* Left atrial diameter less than 55mm assessed by transthoracic echocardiography\n* Renal insufficiency requiring dialysis\n* Heart valve disease requiring invasive treatment\n* Heart anomaly requiring regular controls and/or invasive treatment'}, 'identificationModule': {'nctId': 'NCT01791218', 'acronym': 'FIN-PVI', 'briefTitle': 'Surgical Pulmonary Vein Isolation Efficiency Study', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study', 'orgStudyIdInfo': {'id': 'KUH5101071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CABG, AVR or CABG+AVR and PVI', 'description': 'Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis (AVR) or combination (CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation (PVI) in CBP prior to occlusion and CABG', 'interventionNames': ['Procedure: CABG, AVR or CABG+AVR and PVI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CABG, AVR or CABG+AVR', 'description': 'Coronary artery bypass (CABG), aortic valve replacement for aortic stenosis(AVR) or combination(CABG+AVR) using cardio-pulmonary bypass (CBP) and occlusion. No operative procedures for the treatment of atrial fibrillation', 'interventionNames': ['Procedure: CABG, AVR or CABG+AVR']}], 'interventions': [{'name': 'CABG, AVR or CABG+AVR and PVI', 'type': 'PROCEDURE', 'armGroupLabels': ['CABG, AVR or CABG+AVR and PVI']}, {'name': 'CABG, AVR or CABG+AVR', 'type': 'PROCEDURE', 'armGroupLabels': ['CABG, AVR or CABG+AVR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70211', 'city': 'Kuopio', 'state': 'Eastern Finland', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}