Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-24 @ 7:43 PM
Study NCT ID:
NCT02799693
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramural Needle Ablation for Ventricular Tachycardia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from hospitalization for recurrent VT during 6 months following ablation', 'timeFrame': '6 months', 'description': 'Control of VT as defined by: freedom from hospitalization for recurrent VT during the 6 months following ablation'}, {'measure': 'Absence of serious adverse events attributable to the procedure which occur within 30 days of the ablation procedure', 'timeFrame': '6 months', 'description': 'Absence of all serious adverse events that are potentially procedure related and occur within 30 days of the ablation procedure.'}], 'secondaryOutcomes': [{'measure': 'Acute Procedural Success', 'timeFrame': '6 hours', 'description': 'Termination of at least one clinical or presumptive clinical monomorphic VT by RF ablation or rendering that VT no longer inducible'}, {'measure': 'Acute procedural complications', 'timeFrame': '24 hours', 'description': 'Any complications occurring within 24 hours post procedure described as probably or possibly related to the VT catheter ablation procedure'}, {'measure': 'Number of inducible VT morphologies', 'timeFrame': '6 hours', 'description': 'Number of VT morphologies induced during catheter ablation'}, {'measure': 'ICD therapy - shocks', 'timeFrame': '3 months', 'description': 'Number of VT events treated with appropriate ICD shocks at 3 months post procedure'}, {'measure': 'ICD therapy - shocks', 'timeFrame': '6 months', 'description': 'Number of VT events treated with appropriate ICD shocks at 6 months post procedure'}, {'measure': 'ICD therapy - ATP', 'timeFrame': '3 months', 'description': 'Number of VT events treated with antitachycardia pacing (without shock) during 3 months follow-up post-ablation procedure'}, {'measure': 'ICD therapy - ATP', 'timeFrame': '6 months', 'description': 'Number of VT events treated with antitachycardia pacing (without shock) during 6 months follow-up post-ablation procedure'}, {'measure': 'ICD Therapy', 'timeFrame': '3 months', 'description': 'Number of VT events treated with antitachycardia pacing (with shock) during 3 months follow-up post-ablation procedure'}, {'measure': 'ICD Therapy', 'timeFrame': '6 months', 'description': 'Number of VT events treated with antitachycardia pacing (with shock) during 6 months follow-up post-ablation procedure'}, {'measure': 'VT storm', 'timeFrame': '3 months', 'description': 'Number of VT storm events during 3 months follow-up'}, {'measure': 'VT storm', 'timeFrame': '6 months', 'description': 'Number of VT storm events during 6 months follow-up'}, {'measure': 'VT events', 'timeFrame': '3 months', 'description': 'Difference in number of VT events during 3 months prior to and following procedure'}, {'measure': 'VT events', 'timeFrame': '6 months', 'description': 'Difference in number of VT events during 6 months prior to and following procedure'}, {'measure': 'Recurrent VT', 'timeFrame': '6 months', 'description': 'Time to first recurrent VT'}, {'measure': 'Appropriate ATP', 'timeFrame': '6 months', 'description': 'Time to first appropriate ATP'}, {'measure': 'Appropriate ICD shock', 'timeFrame': '6 months', 'description': 'Time to first appropriate ICD shock'}, {'measure': 'VT Storm', 'timeFrame': '6 months', 'description': 'Time to first VT storm'}, {'measure': 'Antiarrhythmic Drug Therapy', 'timeFrame': '6 months', 'description': 'Changes in antiarrhythmic drug therapy post-procedure'}, {'measure': 'Total appropriate ICD shocks', 'timeFrame': '3 months', 'description': 'Total number of appropriate ICD shocks during 3 months follow up'}, {'measure': 'Total appropriate ICD shocks', 'timeFrame': '6 months', 'description': 'Total number of appropriate ICD shocks during 6 months follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Catheter Ablation', 'Ventricular Tachycardia', 'Intramural Needle Catheter'], 'conditions': ['Recurrent Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.', 'detailedDescription': 'This is an observational prospective cohort study of patients undergoing needle catheter ablation. Patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for VT will be offered participation. Data will be collected during the procedure and during follow-up. Patients will be monitored in hospital for complications and during 6 months follow-up.\n\nData Collection:\n\nBaseline Data: Baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures.\n\nProcedural data: Details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure.\n\nFollowup data: Adverse events will be collected for events which are documented during enrollment and follow-up. During follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recurrent ventricular tachycardia who have failed radiofrequency catheter ablation who are undergoing intramural needle catheter ablation procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias.\n\nExclusion Criteria:\n\n* Patient refusal to participate'}, 'identificationModule': {'nctId': 'NCT02799693', 'briefTitle': 'Intramural Needle Ablation for Ventricular Tachycardia', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Outcomes of Intramural Needle Ablation for Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation', 'orgStudyIdInfo': {'id': 'Sapp002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recurrent VT failing RF ablation', 'description': 'Patients undergoing intramural needle catheter ablation of recurrent monomorphic ventricular tachycardia who have failed prior attempted radiofrequency catheter ablation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'John Sapp, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Sapp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD FRCPC FRHS', 'investigatorFullName': 'John Sapp', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}