Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04657705
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2020-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of intraoperative complications', 'timeFrame': 'Day 1', 'description': 'The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications)'}, {'measure': 'The inducibility of the clinical VT at the end of ablation procedure', 'timeFrame': 'Day 1', 'description': 'The number of patients with inducible VT at the end of the ablation procedure'}, {'measure': 'The number of recurrent ventricular tachycardias', 'timeFrame': 'Up to one year', 'description': 'The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure'}, {'measure': 'The number of episodes of ICD therapy', 'timeFrame': 'Up to one year', 'description': 'The number of episodes of ICD therapy on one-year follow-up period after single procedure'}], 'secondaryOutcomes': [{'measure': 'Freedom from recurrent VT', 'timeFrame': '3 months', 'description': 'Time to the first episode of VT on 3 months follow-up period after single procedure'}, {'measure': 'The total time of ablation procedure', 'timeFrame': 'Up to one year', 'description': 'The total time of ablation procedure'}, {'measure': 'The total time of fluoroscopy', 'timeFrame': 'Up to one year', 'description': 'The total time of fluoroscopy'}, {'measure': 'The total number of RF exposures', 'timeFrame': 'Up to one year', 'description': 'The total number of RF exposures'}, {'measure': 'The total time of RF exposures', 'timeFrame': 'Up to one year', 'description': 'The total time of RF exposures'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to one year', 'description': 'All-cause mortality (Time to any death occurring at any time on one-year follow-up period )'}, {'measure': 'The number of redo ablation procedures for recurrent VT', 'timeFrame': 'Up to one year', 'description': 'The number of redo ablation procedures for recurrent VT on one-year follow-up period'}, {'measure': 'The number of appropriate and unappropriated ICD therapies', 'timeFrame': 'Up to one year', 'description': 'The number of appropriate and unappropriated ICD therapies'}, {'measure': 'The number of antiarrhythmic drugs', 'timeFrame': 'Up to one year', 'description': 'The number of antiarrhythmic drugs on one-year follow-up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Power Radio Frequency Energy', 'Ventricular Tachycardia', 'Structural Heart Disease'], 'conditions': ['Ventricular Tachycardia', 'Heart Diseases']}, 'descriptionModule': {'briefSummary': "Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure.\n\nHypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease.\n\nPurpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.", 'detailedDescription': 'Background: Patient\'s freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure.\n\nHypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease.\n\nPurpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.\n\nTasks:\n\n1. To analyze the number of intraoperative complications in both groups\n2. To evaluate the number of recurrent ventricular tachycardias and the number of episodes of CDI therapy in the long-term follow-up period\n3. To estimate the time of onset of the first episode of VT and the overall burden of VT in the long-term follow-up period\n4. To compare the total time of surgery, fluoroscopy, the number and total time of RF exposure, as well as the ablation index in relation to the "acute" and separated efficiency of ablation in the study groups\n5. To estimate all-cause mortality in both groups\n6. The number of repeated ablation for recurrent VT\n7. The number of justified and unfounded CDI therapies\n8. To analyze the long-term burden of antiarrhythmic therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients after myocardial infarction (at least 3 months before enrollment in the study)\n2. Stable, documented, monomorphic VT, confirmed by ECG and / or CMECG and / or EGM of any implanted device, having appropriate rhythm discrimination algorithms\n3. Patients who have signed the informed consent\n\nExclusion Criteria:\n\n1. Acute myocardial ischemia\n2. A reversible cause of VT (e.g. drug arrhythmia), recently(up to 30 days) suffered from acute coronary syndrome, coronary revascularization (\\<90 days for bypass surgery, \\<30 days for percutaneous coronary intervention), or having functional class IV angina.\n3. Thrombosis of the left ventricle\n4. Patients who have been implanted the mechanical prostheses in the aortic and mitral positions.\n5. Patients who have been performed the catheter RFA for VT.\n6. Renal failure (creatinine clearance \\<15 ml / min),\n7. Patients with NYHA functional class IV heart failure\n8. Patients with a medical condition that may limit survival to less than 1 year\n9. Patients with myocardial infarction with ST-segment elevation or MI without ST-segment elevation, transferred less than 30 days ago.\n10. Patients who haven't signed the informed consent"}, 'identificationModule': {'nctId': 'NCT04657705', 'briefTitle': 'Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Federal Research Clinical Center of Federal Medical & Biological Agency, Russia'}, 'officialTitle': 'Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease', 'orgStudyIdInfo': {'id': 'BURN VT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High power ablation', 'description': 'High power ablation parameters (50-55 W)', 'interventionNames': ['Procedure: High power ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard ablation power', 'description': 'Standard ablation power parameters (40-45 W)', 'interventionNames': ['Procedure: Standard ablation power']}], 'interventions': [{'name': 'High power ablation', 'type': 'PROCEDURE', 'description': 'High power ablation parameters (50-55 W)', 'armGroupLabels': ['High power ablation']}, {'name': 'Standard ablation power', 'type': 'PROCEDURE', 'description': 'Standard ablation power parameters (40-45 W)', 'armGroupLabels': ['Standard ablation power']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78749', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Institute', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Bad Bevensen', 'country': 'Germany', 'facility': 'Heart and Vascular Center', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}, {'zip': '115682', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal Research Clinical Center of Federal Medical & Biological Agency', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117997', 'city': 'Moscow', 'country': 'Russia', 'facility': 'National Medical Research Center of Surgery named after A. Vishnevsky', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'I.M. Sechenov First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'National Medical Research Center of Cardiology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'overallOfficials': [{'name': 'Sergey V. Korolev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal Research Clinical Center FMBA Russia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no current plan to share individual participant data (IPD).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Research Clinical Center of Federal Medical & Biological Agency, Russia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Meshalkin National Medical Research Center, Ministry of Health of Russian Federation', 'class': 'OTHER_GOV'}, {'name': 'Heart and Vascular Center Bad Bevensen, Germany', 'class': 'UNKNOWN'}, {'name': 'National Medical Research Center for Cardiology, Ministry of Health of Russian Federation', 'class': 'OTHER_GOV'}, {'name': 'National Research Center of Surgery, Russia', 'class': 'OTHER_GOV'}, {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, {'name': 'Texas Cardiac Arrhythmia Institute, Austin, Texas', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}