Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-26 @ 11:49 AM
Study NCT ID:
NCT02389218
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2015-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011405', 'term': 'Propafenone'}, {'id': 'D013015', 'term': 'Sotalol'}, {'id': 'D005424', 'term': 'Flecainide'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-17', 'size': 196388, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-27T02:49', 'hasProtocol': True}, {'date': '2023-07-06', 'size': 66463, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-07T02:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinus rhythm', 'timeFrame': 'one year', 'description': 'Sinus rhythm at one year'}], 'secondaryOutcomes': [{'measure': 'Reduction LA volume', 'timeFrame': 'one year', 'description': 'Reduction left atrial volume in successfully treated patients'}, {'measure': 'Number of cardioversions', 'timeFrame': 'one year', 'description': 'Number of cardioversions'}, {'measure': 'Percentage on anti arrhythmic drugs (AAD)', 'timeFrame': '6 months', 'description': 'Percentage on AAD in each group'}, {'measure': 'Percentage on AAD', 'timeFrame': '12 months', 'description': 'Percentage on AAD in each group'}, {'measure': 'Vascular complications', 'timeFrame': 'one year', 'description': 'Vascular complications, including tamponade'}, {'measure': 'Stroke, transient ischemic attack (TIA)', 'timeFrame': 'one year', 'description': 'Stroke, TIA (symptomatic)'}, {'measure': 'Serious adverse events (SAE)', 'timeFrame': 'one year', 'description': 'Adverse events leading to admission or death'}, {'measure': 'Freedom of AF', 'timeFrame': 'one year', 'description': 'Freedom of atrial fibrillation with all means'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'cryoablation', 'catheter ablation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '18955409', 'type': 'BACKGROUND', 'citation': 'Van Belle Y, Janse P, Theuns D, Szili-Torok T, Jordaens L. One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation. Europace. 2008 Nov;10(11):1271-6. doi: 10.1093/europace/eun218.'}]}, 'descriptionModule': {'briefSummary': 'Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.', 'detailedDescription': 'The total AF history should be shorter than 24 months. Symptomatic patients can be included if they have had within the last year at least 2 episodes of documented AF, lasting minimal 30 sec. One episode in the entire history should have lasted more than 48 h, requiring electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.\n\nAll patients eligible for the study will sign informed consent, have an echocardiogram prior to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.\n\nPrior to randomization, and after inclusion it is suggested to the local investigators to perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study ) in eligible patients to assess the anatomy and the left atrial volume. The results should not influence the strategy of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 21 years and legally capable\n* First documentation or history of symptomatic AF more than 30 sec within the last 2 years\n* Twice AF within the last year\n* One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days\n* Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone\n* Left ventricular ejection fraction estimated \\> 45%\n* LA diameter \\< 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)\n* CHADS2 ≤ 2\n* Failed AAD strategy, or untreated with AAD\n* No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\> 75 yrs\n* CHF\n* Ischemic heart disease as known in the history\n* (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd \\> 14 mm)\n* Hyperthyroidism\n* Congenital heart disease\n* Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies\n* Contra-indications to AAD\n* Long QT syndrome\n* Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)\n* Pure (typical) atrial flutter as documented on one occasion'}, 'identificationModule': {'nctId': 'NCT02389218', 'acronym': 'METACSA', 'briefTitle': 'A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent Atrial Fibrilation', 'orgStudyIdInfo': {'id': '2013/1113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoablation', 'description': 'Cryoballoon single ablation (as described in the reference) at entry after randomization to this group. Single procedure,not to be repeated.', 'interventionNames': ['Device: single ablation (CryoBalloonAblation (CBA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug', 'description': 'Conventional, available anti arrhythmic drugs (propafenone, sotalol or flecainide), in a first stage, sequential, with amiodarone in second stage', 'interventionNames': ['Drug: sequential drug adjustment (propafenone, sotalol or flecainide)']}], 'interventions': [{'name': 'single ablation (CryoBalloonAblation (CBA)', 'type': 'DEVICE', 'description': 'Cryoablation at entry, after randomization to this group', 'armGroupLabels': ['Cryoablation']}, {'name': 'sequential drug adjustment (propafenone, sotalol or flecainide)', 'type': 'DRUG', 'description': 'Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone', 'armGroupLabels': ['Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels Heart Centre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Dept Cardiologie', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Luc Jordaens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}