Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT03343860
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Ablation of All Inducible AT Post AF Ablation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure.', 'timeFrame': 'During 12 months follow-up', 'description': 'There will be a 1-months blanking period after ATPAF ablation. A repeated left atrial ablation at any time (even during the blanking period) will be considered as a recurrence.'}], 'secondaryOutcomes': [{'measure': 'The number of non-inducible ATPAFA during a redo procedure', 'timeFrame': 'At repeat procedure(s) during the 12 months follow-up'}, {'measure': 'Incidence of repeat procedures', 'timeFrame': 'During 12 months follow-up'}, {'measure': 'Incidence of procedure related complications', 'timeFrame': 'During 12 months follow-up'}, {'measure': 'Procedure time', 'timeFrame': 'Baseline'}, {'measure': 'Fluoroscopy duration', 'timeFrame': 'Baseline'}, {'measure': 'Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure', 'timeFrame': 'At repeat procedure(s) during the 12 months follow-up', 'description': 'To evaluate the correlation between the ATPAFA mechanism during the index procedure with potential AT mechanism during the follow up (in the case of AT recurrence)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Tachycardia', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (\\~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.\n\nMain objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.\n\nSecondary objectives:\n\nTo evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female Adults (≥18 years old)\n* Patients with stable ATPAF at least two months after the first AF ablation procedure.\n* Consent signed by the patient after reading the information leaflet\n\nExclusion Criteria:\n\n* Mental or physical inability to take part in the study\n* Spontaneous AF in the EP lab\n* Presence of any pulmonary vein stents\n* Presence of any pre-existing pulmonary vein stenosis\n* Presence of any cardiac valve prosthesis\n* Clinically significant mitral valve regurgitation or stenosis\n* Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months\n* Unstable angina\n* Any cardiac surgery within the last 3 months\n* NYHA class III or IV congestive heart failure\n* Uncontrolled hyperthyroidism'}, 'identificationModule': {'nctId': 'NCT03343860', 'acronym': 'INDUCATH', 'briefTitle': 'Catheter Ablation of All Inducible AT Post AF Ablation', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'officialTitle': 'Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study', 'orgStudyIdInfo': {'id': '2097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.', 'interventionNames': ['Procedure: AT case 1.1', 'Procedure: AT case 1.2', 'Procedure: AT case 1.3', 'Procedure: AT case 1.4', 'Procedure: SR Case 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non inducibility', 'description': 'PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) .', 'interventionNames': ['Procedure: AT case 2.1', 'Procedure: AT case 2.2', 'Procedure: AT case 2.3', 'Procedure: AT case 2.4', 'Procedure: SR Case 2']}], 'interventions': [{'name': 'AT case 1.1', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.', 'armGroupLabels': ['Conventional']}, {'name': 'AT case 2.1', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)', 'armGroupLabels': ['Non inducibility']}, {'name': 'AT case 1.2', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of termination to another AT, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.', 'armGroupLabels': ['Conventional']}, {'name': 'AT case 1.3', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps', 'armGroupLabels': ['Conventional']}, {'name': 'AT case 1.4', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.', 'armGroupLabels': ['Conventional']}, {'name': 'AT case 2.2', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of termination to another AT, ablation of the subsequent AT will be performed until sinus rhythm restoration. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)', 'armGroupLabels': ['Non inducibility']}, {'name': 'AT case 2.3', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)', 'armGroupLabels': ['Non inducibility']}, {'name': 'AT case 2.4', 'type': 'PROCEDURE', 'description': 'In the case of AT at the time of ablation :\n\nIn the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)', 'armGroupLabels': ['Non inducibility']}, {'name': 'SR Case 1', 'type': 'PROCEDURE', 'description': 'In the case of SR at the time of ablation:\n\nPV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps.', 'armGroupLabels': ['Conventional']}, {'name': 'SR Case 2', 'type': 'PROCEDURE', 'description': 'In the case of SR at the time of ablation:\n\nPV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 10 consecutive AT)', 'armGroupLabels': ['Non inducibility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Department Clinical Trial Cardiology', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '33304', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Cardiologique d Haut Leveque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '55131', 'city': 'Munich', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'St Thomas Hospital London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Sebastien Knecht, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sebastien.knecht@azsintjan.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Sebastien Knecht', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}