Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-28 @ 6:51 PM
Study NCT ID:
NCT03634592
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AF Ablation With the Ablation Index
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'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from atrial fibrillation', 'timeFrame': '1 year', 'description': "Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms."}], 'secondaryOutcomes': [{'measure': 'Acute complications', 'timeFrame': '30 days', 'description': 'Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) whithin 30 days after ablation. Data will be collected using a web-based system with electronic case report forms.'}, {'measure': 'Procedure time', 'timeFrame': '180 minutes', 'description': 'Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes.'}, {'measure': 'Fluoroscopy time', 'timeFrame': '24 hours', 'description': 'Fluoroscopy duration within the procedure'}, {'measure': 'Electrical reconduction', 'timeFrame': '2 years', 'description': 'Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.', 'detailedDescription': 'This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (both males and females aged 18-79 years) with indications to atrial fibrillation ablation undergoing radiofrequency catheter pulmonary vein isolation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indications for catheter ablation of atrial fibrillation;\n* signed informed consent\n\nExclusion Criteria:\n\n* Presence of contraindications to AF ablation'}, 'identificationModule': {'nctId': 'NCT03634592', 'briefTitle': 'AF Ablation With the Ablation Index', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}, 'officialTitle': 'A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology', 'orgStudyIdInfo': {'id': 'AF0718NR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE', 'description': 'Radiofrequency catheter pulmonary vein isolation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}