Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-25 @ 11:57 AM
Study NCT ID:
NCT02008461
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of episodes of atrial fibrillation', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'serious adverse events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Supra-ventricular Tachyarrhythmias']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://meshalkin.ru', 'label': 'State Research Institute of Circulation Pathology Official Site'}]}, 'descriptionModule': {'briefSummary': 'The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome\n* secondary atrial fibrillation\n\nExclusion Criteria:\n\n* congestive heart failure\n* LV ejection fraction \\< 35%\n* left atrial diameter \\> 60 mm'}, 'identificationModule': {'nctId': 'NCT02008461', 'briefTitle': 'Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'orgStudyIdInfo': {'id': 'BT_SVT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RFA', 'description': 'Mapping and radiofrequency ablation are performed by using standard methods.', 'interventionNames': ['Procedure: radiofrequency ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RFA+BT injection', 'description': 'Mapping and radiofrequency ablation are performed by using standard methods.\n\nInjection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).', 'interventionNames': ['Procedure: radiofrequency ablation', 'Drug: botulinum toxin injection']}], 'interventions': [{'name': 'radiofrequency ablation', 'type': 'PROCEDURE', 'armGroupLabels': ['RFA', 'RFA+BT injection']}, {'name': 'botulinum toxin injection', 'type': 'DRUG', 'armGroupLabels': ['RFA+BT injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Rochester', 'state': 'New York', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'CONTACT', 'email': 'E.Pokushalov@gmail.com', 'phone': '+79139254858'}, {'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Evgeny Pokushalov, MD, PhD', 'role': 'CONTACT', 'email': 'e.pokushalov@gmail.com', 'phone': '+79139254858'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}