Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 10:54 AM
Study NCT ID:
NCT02528604
Status:
COMPLETED
Last Update Posted:
2018-09-27
First Post:
2015-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF recurrence', 'timeFrame': '12 months', 'description': 'Time to recurrence of persistent AF'}], 'secondaryOutcomes': [{'measure': 'Patient experience of procedure', 'timeFrame': 'Baseline', 'description': 'Patient experience of each procedure will be assessed by validated questionnaires'}, {'measure': 'Total costs of the treatment options', 'timeFrame': '12 months'}, {'measure': 'AF recurrence >2minutes', 'timeFrame': '12 months', 'description': 'Time to recurrence of AF episode \\> 2 minutes'}, {'measure': 'Symptoms / QOL', 'timeFrame': '12 months', 'description': 'To assess differences in symptoms and QOL'}, {'measure': 'Exercise performance', 'timeFrame': '12 months', 'description': 'To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.'}, {'measure': 'AF burden', 'timeFrame': '12 months', 'description': 'To measure the three treatment effects on AF burden'}, {'measure': 'Sleep apnoea', 'timeFrame': '6 months', 'description': 'To assess the impact of the three treatment options on sleep apnoea scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Catheter Ablation', 'Permanent pacemaker', 'AV node ablation', 'Electrical Cardioversion', 'Implantable loop recorder'], 'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.', 'detailedDescription': "the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:\n\n1. Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment.\n2. Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation.\n3. Left atrial catheter ablation.\n\nThese treatment options have not been directly compared and each has their own advantages and disadvantages.\n\n1. DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times.\n2. Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform.\n3. Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic persistent atrial fibrillation of less than 1-year duration.\n* Patients must be over 65 years old.\n* Patients give informed consent prior to participating in this study.\n\nExclusion Criteria:\n\n* Paroxysmal atrial fibrillation.\n* Long-standing persistent or permanent atrial fibrillation.\n* Previous pacemaker implantation.\n* Previous atrial ablation.\n* Patient is unable to take warfarin or other oral anti-coagulant medication.\n* Patient is suffering with unstable angina in last one week.\n* Patient has had a myocardial infarction within last two months.\n* Patient is expecting or has had major cardiac surgery within last two months.\n* Patient is participating in a conflicting study.\n* Patient is unable to perform exercise testing.\n* Patient is mentally incapacitated and cannot consent or comply with follow-up.\n* Patient has New York Heart Association (NYHA) class III/IV heart failure.\n* Patient has left ventricular ejection fraction (LVEF) less than 35% not secondary to tachycardia.\n* Pregnancy.\n* Patient suffers with other cardiac rhythm disorders.\n* Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).'}, 'identificationModule': {'nctId': 'NCT02528604', 'acronym': 'CAPAPAF-65', 'briefTitle': 'Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Eastbourne General Hospital'}, 'officialTitle': 'Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study', 'orgStudyIdInfo': {'id': 'CAPAPAF-65 V2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Catheter Ablation', 'description': 'Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder.', 'interventionNames': ['Procedure: Catheter ablation', 'Device: Implantable loop recorder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pacemaker and AV node ablation', 'description': 'Participants will have a permanent pacemaker implant followed by AV node ablation', 'interventionNames': ['Procedure: Pacemaker and AV node ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DC cardioversion', 'description': 'Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder.', 'interventionNames': ['Procedure: DC Cardioversion', 'Device: Implantable loop recorder']}], 'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE', 'description': 'Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.', 'armGroupLabels': ['Catheter Ablation']}, {'name': 'Pacemaker and AV node ablation', 'type': 'PROCEDURE', 'description': 'Permanent pacemaker implant followed by AV node ablation', 'armGroupLabels': ['Pacemaker and AV node ablation']}, {'name': 'DC Cardioversion', 'type': 'PROCEDURE', 'description': 'Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.', 'armGroupLabels': ['DC cardioversion']}, {'name': 'Implantable loop recorder', 'type': 'DEVICE', 'armGroupLabels': ['Catheter Ablation', 'DC cardioversion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN21 2UD', 'city': 'Eastbourne', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Eastbourne District General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'TN37 7RD', 'city': 'Saint Leonards-on-Sea', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Conquest Hospital', 'geoPoint': {'lat': 50.85565, 'lon': 0.5452}}], 'overallOfficials': [{'name': 'Rick A Veasey, MRCP, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Cardiologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastbourne General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Rick Veasey', 'investigatorAffiliation': 'Eastbourne General Hospital'}}}}