Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01360918
Status:
TERMINATED
Last Update Posted:
2016-07-07
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Inclusion rate insufficiënt', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-25', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of atrial fibrillation', 'timeFrame': 'one year', 'description': 'The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'One year', 'description': 'Secondary objectives include the duration of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* EHRA class ≤ 2\n* Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery\n* Patients will have elective coronary surgery planned Able of providing informed consent\n\nExclusion Criteria:\n\n* Patients ≥70 years of age\n* Pregnancy Patients with contraindications for oral anticoagulant agents\n* Patients undergoing emergency operation\n* Patients undergoing concomitant valve replacement\n* Severely enlarged LA (\\>50 mm) on echocardiography\n* Prior AF ablation or AF surgery'}, 'identificationModule': {'nctId': 'NCT01360918', 'acronym': 'CONTROL-AF', 'briefTitle': 'Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medisch Spectrum Twente'}, 'officialTitle': 'Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery', 'orgStudyIdInfo': {'id': 'NL35192.044.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'interventionNames': ['Other: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulmonary vein isolation', 'interventionNames': ['Device: Epicardial pulmonary vein isolation']}], 'interventions': [{'name': 'Epicardial pulmonary vein isolation', 'type': 'DEVICE', 'otherNames': ['Medtronic Cardioblate BP2'], 'description': 'After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.', 'armGroupLabels': ['Pulmonary vein isolation']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Enschede', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}], 'overallOfficials': [{'name': 'Marcoen Scholten, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medisch Spectrum Twente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medisch Spectrum Twente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation of Cardiovascular Research and Education Enschede', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'B. Oude Velthuis MD.', 'investigatorFullName': 'B. Oude Velthuis', 'investigatorAffiliation': 'Medisch Spectrum Twente'}}}}