Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT03435393
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ripple Mapping for Epicardial Mapping of Brugada Syndrome
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-15', 'studyFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication of Brugada syndrome pattern', 'timeFrame': '24h post procedure', 'description': 'Disappearance of type 1 Brugada pattern on post-procedure ECG'}], 'secondaryOutcomes': [{'measure': 'Freedom from ventricular arrhythmias', 'timeFrame': '12 months post-procedure', 'description': 'No documentation of sustained ventricular tachycardia or ventricular fibrillation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brugada Syndrome']}, 'descriptionModule': {'briefSummary': 'Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Brugada syndrome and an episode of ventricular tachycardia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brugada syndrome patients requiring ablation\n\nExclusion Criteria:\n\n* Patients not able to consent'}, 'identificationModule': {'nctId': 'NCT03435393', 'briefTitle': 'Ripple Mapping for Epicardial Mapping of Brugada Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University College London Hospitals'}, 'officialTitle': 'Ripple-Mapping for the Detection of Long Duration Action Potential Areas in Patients With Brugada Syndrome', 'orgStudyIdInfo': {'id': 'Barts_Brugada'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE', 'description': 'Mapping of the epicardium and ablating areas of long fractionated potentials'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mauricio Scanavacca, PhD', 'role': 'CONTACT', 'email': 'mauricio.scanavacca@gmail.com', 'phone': '+55 11 2661-5000'}], 'facility': 'Instituto do Coracao', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Pedro Adragao, PhD', 'role': 'CONTACT', 'email': 'padragao@gmail.com', 'phone': '+351 21 043 1000'}], 'facility': 'Hospital de Santa Cruz', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rui Providencia, PhD', 'role': 'CONTACT', 'email': 'rui_providencia@yahoo.com', 'phone': '+44207 3777 000.'}], 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient data will be anonymised'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College London Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Consultant, MD PhD', 'investigatorFullName': 'Rui Providência', 'investigatorAffiliation': 'University College London Hospitals'}}}}