Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 7:02 AM
Study NCT ID:
NCT01503268
Status:
WITHDRAWN
Last Update Posted:
2013-06-21
First Post:
2011-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study methodology redesigned', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-19', 'studyFirstSubmitDate': '2011-12-30', 'studyFirstSubmitQcDate': '2012-01-03', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in AF burden after ablation', 'timeFrame': 'One year', 'description': 'Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder'}, {'measure': 'Time to recurrence of persistent AF', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence of atrial fibrillation after ablation', 'timeFrame': 'One year', 'description': 'Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period'}, {'measure': 'Time to recurrence of symptomatic atrial fibrillation after ablation', 'timeFrame': 'One year', 'description': 'Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period'}, {'measure': 'New MRI-detected subclinical cerebral ischaemia', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Ablation', 'Percutaneous ablation', 'Minimally-invasive thoracoscopic ablation', 'Implantable loop recorder'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy.\n\nAblation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall.\n\nBecause AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).\n\nIn this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic persistent atrial fibrillation\n* Age over 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI safe.\n* Patients unable to undergo general anaesthesia for AF ablation.\n* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery\n* Previous thoracic surgery\n* Participation in a conflicting study\n* Participants who are mentally incapacitated and cannot consent or comply with follow-up\n* Pregnancy\n* Other cardiac rhythm disorders'}, 'identificationModule': {'nctId': 'NCT01503268', 'acronym': 'ACTUAL', 'briefTitle': 'Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study', 'organization': {'class': 'OTHER', 'fullName': 'Eastbourne General Hospital'}, 'officialTitle': 'Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders', 'orgStudyIdInfo': {'id': 'ACTUAL 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous ablation', 'interventionNames': ['Device: Implantation of implantable loop recorder', 'Procedure: Percutaneous ablation of atrial fibrillation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical ablation', 'interventionNames': ['Device: Implantation of implantable loop recorder', 'Procedure: Surgical ablation of atrial fibrillation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DCCV', 'description': 'Direct current cardioversion', 'interventionNames': ['Device: Implantation of implantable loop recorder']}], 'interventions': [{'name': 'Implantation of implantable loop recorder', 'type': 'DEVICE', 'description': 'An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.', 'armGroupLabels': ['DCCV', 'Percutaneous ablation', 'Surgical ablation']}, {'name': 'Percutaneous ablation of atrial fibrillation', 'type': 'PROCEDURE', 'description': 'Catheter-based percutaneous ablation of atrial fibrillation', 'armGroupLabels': ['Percutaneous ablation']}, {'name': 'Surgical ablation of atrial fibrillation', 'type': 'PROCEDURE', 'description': 'Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation', 'armGroupLabels': ['Surgical ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'BN21 2UD', 'city': 'Eastbourne', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Eastbourne District General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}], 'overallOfficials': [{'name': 'A N Sulke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastbourne General Hospital'}, {'name': 'S S Furniss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastbourne General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastbourne General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Neil Sulke', 'investigatorAffiliation': 'Eastbourne General Hospital'}}}}