Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-28 @ 8:52 PM
Study NCT ID:
NCT05195268
Status:
WITHDRAWN
Last Update Posted:
2022-09-29
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Decision to discontinue in light of new evidence demonstrating that the intervention in question is not effective.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Outcome: Number of patients with procedural complications (<2 months post procedure)', 'timeFrame': 'Within 2 months of protocol-required invasive procedures', 'description': 'Number of patients suffering a procedure-related complication within 2 months of an invasive procedure as defined in the study protocol'}, {'measure': 'Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations', 'timeFrame': '12 months', 'description': 'Number of patients who are hospitalised (planned or unplanned) for cardiovascular reasons'}], 'primaryOutcomes': [{'measure': 'Time to first day with ATA burden of 12 hours or greater', 'timeFrame': 'From 3 months post ablation to 12 months', 'description': 'Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation'}], 'secondaryOutcomes': [{'measure': 'Time to first day with ATA burden of 24 hours', 'timeFrame': 'From 3 months post ablation to 12 months', 'description': 'Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation'}, {'measure': 'Time to first day with ATA burden of 60 minutes or greater', 'timeFrame': 'From 3 months post ablation to 12 months', 'description': 'Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation'}, {'measure': 'Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12', 'timeFrame': '12 months', 'description': 'AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the number of patients who achieve greater than or equal to 75% reduction.'}, {'measure': 'Reduction in burden of AF between pre-ablation and months 3-12', 'timeFrame': '12 months', 'description': 'AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the average % reduction in AF burden between these time periods.'}, {'measure': 'Difference in AFEQT questionnaire between baseline and month 12', 'timeFrame': '12 months', 'description': 'Differences in quality of life indicators as measured by the "AF Effect on QualiTy of life survey" (AFEQT) between baseline and 12 month follow-up'}, {'measure': 'Difference in EQ5D questionnaire between baseline and month 12', 'timeFrame': '12 months', 'description': 'Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up'}, {'measure': 'Difference in VAS between baseline and month 12', 'timeFrame': '12 months', 'description': 'Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up'}, {'measure': 'Use of antiarrhythmic drugs from month 3 onwards', 'timeFrame': 'From 3 months post ablation to 12 months', 'description': 'Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.'}, {'measure': 'Use of direct current cardioversion or repeat ablation', 'timeFrame': 'From 3 months post ablation to 12 months', 'description': 'Number of patients requiring cardioversion or repeat ablation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Posterior wall isolation', 'Ablation', 'Persistent Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).', 'detailedDescription': 'Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF.\n\nA common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF.\n\nThe investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 18 to 80 (inclusive)\n* Patients with symptomatic advanced persistent AF, defined as:\n* AF which does not spontaneously terminate and requires medical intervention (antiarrhythmics or DCCV) to terminate, AND\n* Recurs following cardioversion, AND\n* Is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, CT or MRI) as defined by standard values (for example British Society of Echocardiography or European equivalent) - in the event of uncertainty, Principal Investigator discretion is allowed.\n\nExclusion Criteria\n\n* Any previous catheter (or surgical) ablation for AF (previous ablation for atrial flutter or focal atrial tachycardias are allowable)\n* An indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium\n* Severe left ventricular systolic dysfunction (ejection fraction less than 35%)\n* Recent stroke/transient ischaemic attack within 3 months\n* Inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication\n* Severe kidney function impairment (eGFR less than 30ml/min/1.73m2)\n* Morbid obesity with a body mass index ≥40\n* Extreme frailty (a score of 7,8 or 9 on the Rockwood Clinical Frailty Scale)\n* Severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05195268', 'acronym': 'RABLAP-AF', 'briefTitle': 'Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool Heart and Chest Hospital NHS Foundation Trust'}, 'officialTitle': 'Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF', 'orgStudyIdInfo': {'id': '1349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 - PVI + PWI', 'description': 'These patients will receive pulmonary vein isolation and posterior wall isolation.', 'interventionNames': ['Procedure: Intracardiac Catheter Ablation']}, {'type': 'OTHER', 'label': 'Group 2 - PVI only', 'description': 'These patients will receive pulmonary vein isolation only.', 'interventionNames': ['Procedure: Intracardiac Catheter Ablation']}], 'interventions': [{'name': 'Intracardiac Catheter Ablation', 'type': 'PROCEDURE', 'description': 'Both arms will receive intracardiac catheter ablation procedures as described.', 'armGroupLabels': ['Group 1 - PVI + PWI', 'Group 2 - PVI only']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L14 3PE', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool Heart & Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Dhiraj Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool Heart & Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool Heart and Chest Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, {'name': "St George's University Hospitals NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, {'name': 'South Tees Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}, {'name': 'University Hospitals Dorset NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'University Hospital Birmingham NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}, {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, {'name': 'University of Liverpool', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}