Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 5:10 AM
Study NCT ID:
NCT05685134
Status:
UNKNOWN
Last Update Posted:
2023-01-13
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053840', 'term': 'Brugada Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization will occur during the electrophysiology procedure, and its automatic computerized process will ensure allocation concealment. The study protocol, for obvious reasons, precludes masking the principal investigator (electrophysiology specialist). Participants randomized to the control group will undergo a sham procedure consisting of femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure. Medical follow-up will be standardized with the same protocol for both treatment groups. All medical documents will be unidentified before being evaluated. Outcome raters and statisticians will also be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, single-centre, randomized, sham-controlled, and masked pilot study with two parallel arms, with a 1:1 allocation ratio to ablation or control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of abnormal potentials', 'timeFrame': 'first 30 minutes after the intervention', 'description': 'Electroanatomic duration map'}, {'measure': 'Induction of sustained ventricular arrhythmias by programmed electrical stimulation', 'timeFrame': 'first 30 minutes after the intervention', 'description': 'Programmed electrical stimulation (PES) performed on two sites (right ventricular apex and right ventricular outflow tract, unless the patient had inducible ventricular tachycardia at the first location), with energy of twice the diastolic threshold, using two drive cycles (S1: 600 and 430 ms) up to 3 extra stimuli (S2 to S4) with 200 ms as the shortest coupling time. The PVS result is considered positive if sustained ventricular fibrillation or polymorphic ventricular tachycardia is induced.'}, {'measure': 'Maximum potential duration', 'timeFrame': 'first 30 minutes after the intervention', 'description': 'Maximum length of ventricular signs on bipolar electrogram'}, {'measure': 'Local activation time', 'timeFrame': 'first 30 minutes after the intervention', 'description': 'Measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces'}, {'measure': 'Activation recovery interval', 'timeFrame': 'first 30 minutes after the intervention', 'description': 'Surrogate marker of the action potential duration, measured by unipolar catheters placed in the epicardial and endocardial ventricular surfaces'}], 'secondaryOutcomes': [{'measure': 'Spontaneous type 1 Brugada electrocardiographic pattern in standard12 lead and superior leads electrocardiogram', 'timeFrame': 'up to one year after the procedure', 'description': 'Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces.'}, {'measure': 'Spontaneous type 1 Brugada electrocardiographic pattern in 12 lead 24 hour Holter monitoring', 'timeFrame': 'up to one year after the procedure', 'description': 'Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces during 12 lead 24h Holter ECG Monitoring'}, {'measure': 'Spontaneous type 1 Brugada electrocardiographic pattern during treadmill test', 'timeFrame': 'up to one year after the procedure', 'description': 'Upward ST segment elevation ST-segment elevation ≥2 mm followed by a negative T wave (type 1 Brugada electrocardiographic pattern) in one or more right precordial leads V1 and/or V2 positioned in the second, third, or fourth intercostal spaces, during treadmill test.'}, {'measure': 'Occurrence of life threatening arrhythmic events', 'timeFrame': 'up to one year after the procedure', 'description': 'Occurrence of at least one of the following: arrhythmic syncope, documented sustained ventricular tachycardia or ventricular fibrillation, sudden cardiac death or appropriate implantable cardiac defibrillator therapy'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brugada syndrome', 'Radiofrequency catheter ablation', 'Electroanatomic mapping', 'Invasive electrophysiological study'], 'conditions': ['Brugada Syndrome']}, 'referencesModule': {'references': [{'pmid': '28500178', 'type': 'BACKGROUND', 'citation': 'Pappone C, Brugada J, Vicedomini G, Ciconte G, Manguso F, Saviano M, Vitale R, Cuko A, Giannelli L, Calovic Z, Conti M, Pozzi P, Natalizia A, Crisa S, Borrelli V, Brugada R, Sarquella-Brugada G, Guazzi M, Frigiola A, Menicanti L, Santinelli V. Electrical Substrate Elimination in 135 Consecutive Patients With Brugada Syndrome. Circ Arrhythm Electrophysiol. 2017 May;10(5):e005053. doi: 10.1161/CIRCEP.117.005053.'}, {'pmid': '28948234', 'type': 'BACKGROUND', 'citation': 'Patocskai B, Yoon N, Antzelevitch C. Mechanisms Underlying Epicardial Radiofrequency Ablation to Suppress Arrhythmogenesis in Experimental Models of Brugada Syndrome. JACC Clin Electrophysiol. 2017 Apr;3(4):353-363. doi: 10.1016/j.jacep.2016.10.011. Epub 2016 Dec 21.'}, {'pmid': '35451610', 'type': 'BACKGROUND', 'citation': 'Kotake Y, Barua S, Kazi S, Virk S, Bhaskaran A, Campbell T, Bennett RG, Kumar S. Efficacy and safety of catheter ablation for Brugada syndrome: an updated systematic review. Clin Res Cardiol. 2023 Dec;112(12):1715-1726. doi: 10.1007/s00392-022-02020-3. Epub 2022 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to learn about the electrophysiological and clinical effects of radiofrequency catheter ablation in patients with Brugada syndrome. The main questions it seeks to answer are:\n\n* What are the immediate effects of catheter radiofrequency ablation in cardiac electrophysiology?\n* What is the relation between invasive and clinical features in patients with Brugada syndrome undergoing ablation? Researchers will compare ablation and control groups to see if there is a difference in clinical and invasive markers of the disease in one year of follow-up.', 'detailedDescription': 'Brugada syndrome (BS) is an electric cardiac disorder characterized by a typical electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. Most arrhythmic events occur during rest, fever or under circumstances of increased vagal activity. In the last decade, catheter ablation has emerged as a valuable and potentially curative therapy for patients with BS. However, little is known about its mechanisms or long-term effects on clinical and invasive markers. This prospective, single-centre, randomized, sham-controlled, and masked pilot study will investigate the impact of catheter ablation in 20 patients with Brugada syndrome, who will be randomized to ablation or control group, with a 1:1 allocation ratio and clinically followed for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams\n* Patients clinically stable for at least six months before the enrollment\n* Able to cope with follow-up visits up to one year after the intervention\n* Patients who have signed the written informed consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with structural heart disease\n* Patients with a known cardiac or systemic autonomic disorder\n* Patients with a history of previous right ventricular outflow tract ablation'}, 'identificationModule': {'nctId': 'NCT05685134', 'briefTitle': 'Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation: a Prospective, Single-centre, Randomized, Sham-controlled, and Masked Pilot Study', 'orgStudyIdInfo': {'id': 'IIS-470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ablation', 'description': 'Radiofrequency catheter ablation of the abnormal - prolonged and fragmented - electrophysiologic substrate of Brugada syndrome', 'interventionNames': ['Device: Radiofrequency catheter ablation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Femoral venous punctions, catheter insertion, programmed electrical stimulation and electroanatomic mapping, with a similar duration to the ablation procedure', 'interventionNames': ['Device: Sham procedure']}], 'interventions': [{'name': 'Radiofrequency catheter ablation', 'type': 'DEVICE', 'description': 'Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome', 'armGroupLabels': ['Ablation']}, {'name': 'Sham procedure', 'type': 'DEVICE', 'description': 'Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mauricio Ibrahim Scanavacca, MD; PhD', 'role': 'CONTACT', 'email': 'mauricio.scanavacca@incor.usp.br', 'phone': '+551126615312'}, {'name': 'Mirella Esmanhotto Facin, MD', 'role': 'CONTACT', 'email': 'mirellafacin@gmail.com', 'phone': '+5511970272217'}, {'name': 'Cristiano Pisani, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto do Coração - InCor - HC/FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': "After the article's publication", 'ipdSharing': 'YES', 'description': 'Data sharing will be provided under proper request to the principal investigator', 'accessCriteria': 'Under request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Cardiac Arrhythmias Unit; MD, PhD', 'investigatorFullName': 'Mauricio Ibrahim Scanavacca', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}