Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-26 @ 2:07 AM
Study NCT ID:
NCT06455020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
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'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up', 'timeFrame': '30 days', 'description': 'Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia \\>30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 30-day follow-up.'}], 'secondaryOutcomes': [{'measure': 'Recurrence of ventricular tachycardia during the 30-day follow-up', 'timeFrame': '30 days', 'description': 'Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia \\>30 seconds during the 30-day follow-up.'}, {'measure': 'Cardiovascular re-hospitalization during the 30-day follow-up', 'timeFrame': '30 days', 'description': 'Cardiovascular re-hospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 30-day follow-up.'}, {'measure': 'All-cause mortality during the 30-day follow-up', 'timeFrame': '30 days', 'description': 'All-cause mortality is defined as the death from all causes during the 30-day follow-up.'}, {'measure': 'Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up', 'timeFrame': '1 year', 'description': 'Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia \\>30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 1-year follow-up.'}, {'measure': 'All-cause mortality during the 1-year follow-up', 'timeFrame': '1 year', 'description': 'All-cause mortality is defined as the death from all causes during the 1-year follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catheter ablation', 'Mortality', 'Electrical storm'], 'conditions': ['Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT).', 'detailedDescription': 'The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor, with a high 30-day mortality rate \\>30%, resulting in extremely heavy medical burden. Current guidelines lack specific recommendations for managing this condition. The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. Catheter ablation is only used as the final rescue treatment. Typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. Studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. Early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT. Therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia.\n\nIn this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. Current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. The follow-up duration is 1 year. The primary outcome is a composite outcome of VT recurrence, cardiovascular re-hospitalization, and all-cause mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 to 80 years;\n2. Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy;\n3. Haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure \\<90 mmHg and mean arterial pressure 30 mmHg lower than baseline or \\<70 mmHg, with associated signs of end-organ hypoperfusion);\n4. Electrical storm, defined as \\>3 VT episodes within 24 hours.\n\nExclusion Criteria:\n\n1. Reversible causes of ventricular tachycardia or cardiomyopathy;\n2. Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance;\n3. Acute ST-segment-elevation myocardial infarction within 60 days;\n4. Cardiac surgery within 60 days;\n5. Unstable angina;\n6. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06455020', 'briefTitle': 'Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease', 'orgStudyIdInfo': {'id': '2024-vtstorm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Catheter ablation', 'description': 'Patients randomized to the emergency catheter ablation arm will first undergo catheter ablation. Vasopressors, antiarrhythmic drugs, and hemodynamic mechanical support devices will be adopted as needed. All patients will be advised for ICD implantation before discharge.', 'interventionNames': ['Procedure: Catheter ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stepped-care strategies', 'description': 'Patients randomized to the stepped-care strategies arm will undergo a stepwise progressive procedure, with anti-arrhythmic drugs, sedation and anesthesia, and hemodynamic mechanical support devices, that is, the next treatment is only started when the previous sequence of treatment is ineffective, and catheter ablation is only used as the final rescue treatment. All patients will be advised for ICD implantation before discharge.', 'interventionNames': ['Procedure: Stepped-care strategies']}], 'interventions': [{'name': 'Catheter ablation', 'type': 'PROCEDURE', 'description': 'Emergency catheter ablation is defined as ablation performed within 48 hours of hospital admission', 'armGroupLabels': ['Catheter ablation']}, {'name': 'Stepped-care strategies', 'type': 'PROCEDURE', 'description': 'Patients randomized to the stepped-care strategy arm will receive treatment through a systematic, stepwise protocol beginning with anti-arrhythmic drugs, followed by sedation and anesthesia, and progressing to haemodynamic mechanical support devices if earlier treatments prove ineffective. Catheter ablation will be reserved as the final rescue intervention.', 'armGroupLabels': ['Stepped-care strategies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Mengmeng Li', 'role': 'CONTACT', 'email': 'lmm6701@163.com', 'phone': '86+18610650190'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'country': 'China', 'contacts': [{'name': 'Qiming Liu, MD', 'role': 'CONTACT', 'email': 'qimingliu@126.com', 'phone': '86+13873181753'}], 'facility': 'Second Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Kunming', 'country': 'China', 'contacts': [{'name': 'Shaolong Li, MD', 'role': 'CONTACT', 'email': '13700651472@126.com', 'phone': '86+13700651472'}], 'facility': 'The Affiliated YanAn Hospital of KunMing Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Nanjing', 'country': 'China', 'contacts': [{'name': 'Jiangang Zou, MD', 'role': 'CONTACT', 'email': 'jgzou@njmu.edu.cn', 'phone': '86+13605191407'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Deyong Long, MD', 'role': 'CONTACT', 'email': 'dragon2008@vip.sina.com', 'phone': '+86 (010) 84005361'}], 'overallOfficials': [{'name': 'Deyong Long, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}