Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01504451
Status:
UNKNOWN
Last Update Posted:
2014-06-26
First Post:
2011-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 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': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-25', 'studyFirstSubmitDate': '2011-12-30', 'studyFirstSubmitQcDate': '2012-01-03', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF burden', 'timeFrame': '12 months after ablation', 'description': 'Total proportion of time spent in AF as assessed by ILR'}], 'secondaryOutcomes': [{'measure': 'Time to AF recurrence', 'timeFrame': 'Up to one year', 'description': 'Time to recurrence of any AF after ablation'}, {'measure': 'Time to first symptomatic AF recurrence', 'timeFrame': 'Up to one year', 'description': 'Time to first symptomatic AF recurrence as assessed by ILR.'}, {'measure': 'Change in QoL measures', 'timeFrame': '12 months after ablation', 'description': 'Change in Quality of Life measures assessed by questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Ablation', 'Implantable loop recorder'], 'conditions': ['Paroxysmal Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '29092038', 'type': 'DERIVED', 'citation': 'Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.', 'detailedDescription': 'A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic paroxysmal AF suitable for AF ablation\n* Age \\> 18 years old\n* Informed consent to participate in this study.\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* Unable to undergo general anaesthesia for AF ablation.\n* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.\n* Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.\n* Previous thoracic surgery.\n* Participation in a conflicting study.\n* Potential participants who are mentally incapacitated and cannot consent or comply with follow-up\n* Pregnancy\n* Other cardiac rhythm disorders'}, 'identificationModule': {'nctId': 'NCT01504451', 'acronym': 'LAAPITUP 2', 'briefTitle': 'Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study', 'organization': {'class': 'OTHER', 'fullName': 'Eastbourne General Hospital'}, 'officialTitle': 'Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2', 'orgStudyIdInfo': {'id': 'LAAPITUP 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Biosense Webster ablation', 'description': 'Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation', 'interventionNames': ['Device: ILR insertion', 'Procedure: AF ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical ablation', 'description': 'Minimally invasive thoracoscopic surgical AF ablation', 'interventionNames': ['Device: ILR insertion', 'Procedure: AF ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medtronic ablation', 'description': 'Medtronic multi-electrode phased radiofrequency AF ablation', 'interventionNames': ['Device: ILR insertion', 'Procedure: AF ablation']}], 'interventions': [{'name': 'ILR insertion', 'type': 'DEVICE', 'description': 'Insertion of implantable loop recorder', 'armGroupLabels': ['Biosense Webster ablation', 'Medtronic ablation', 'Surgical ablation']}, {'name': 'AF ablation', 'type': 'PROCEDURE', 'description': 'AF ablation', 'armGroupLabels': ['Biosense Webster ablation', 'Medtronic ablation', 'Surgical ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN21 2UD', 'city': 'Eastbourne', 'state': 'E Sussex', 'country': 'United Kingdom', 'facility': 'Eastbourne General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'state': 'Sussex', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}], 'overallOfficials': [{'name': 'Neil Sulke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastbourne General Hospital'}, {'name': 'Stephen S Furniss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastbourne General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neil Sulke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Neil Sulke', 'investigatorAffiliation': 'Eastbourne General Hospital'}}}}