Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-30 @ 2:03 AM
Study NCT ID:
NCT06360003
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Immediate Ablation Success', 'timeFrame': 'At the end of the first procedure', 'description': 'Immediate Ablation Success is determined by the disappearance of ventricular arrhythmia after ablation, that cannot be induced by electrical stimulation and intravenous infusion of isoproterenol.'}, {'measure': 'Rate of Ablation Complication', 'timeFrame': 'At the end of the first procedure', 'description': 'Complications like cardiac tamponade, artery damage'}, {'measure': 'Accuracy of RVOT posterior septal pacing protocol', 'timeFrame': 'At the end of the first procedure', 'description': 'Target site predicted by RVOT posterior septal pacing protocol compared with actual target site and previous ecg criteria'}], 'secondaryOutcomes': [{'measure': 'Incidence of Complications Post-operative', 'timeFrame': 'period of post-operative to hospital discharge, within 7 days', 'description': 'Complications like cardiac tamponade, artery damage'}, {'measure': 'Incidence of Complication', 'timeFrame': '1 months after first procedure', 'description': 'Complications like pericardial effusion, pseudo arterial aneurysm'}, {'measure': 'Rate of Recurrence during Follow up', 'timeFrame': '1 months after first procedure', 'description': 'Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure'}, {'measure': 'Incidence of Complication', 'timeFrame': '3 months after first procedure', 'description': 'Complications like pericardial effusion, pseudo arterial aneurysm'}, {'measure': 'Rate of Recurrence during Follow up', 'timeFrame': '3 months after first procedure', 'description': 'Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventricular Outflow Tract Ventricular Arrhythmias', 'Radio Frequency Catheter Ablation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.\n\nResearches will break the method of this investigation into two steps:\n\nFirst step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.\n\nThe second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign informed consent form\n* Age more than 18 years old\n* Able to understand the purpose of the experiment, voluntarily participate, willing to complete follow-up according to the requirement of the experimental protocol.\n\nExclusion Criteria:\n\n* Severe cardiopulmonary, liver and kidney dysfunction, and inability to tolerate surgery due to coagulation dysfunction\n* Viral myocarditis, myocardial infarction or stroke with a course of less than six months\n* Simultaneously accompanied by malignant tumours, with an expected lifespan of less than or equal to 1 year\n* Severe thoracic deformity\n* Advanced age (more than 90 years old)\n* Other situations that the researcher deems unsuitable for participation in the study'}, 'identificationModule': {'nctId': 'NCT06360003', 'briefTitle': '"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': '"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin: a Single-center, Prospective, Single Blind, Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2024-01-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group', 'interventionNames': ['Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Convention Group', 'interventionNames': ['Procedure: systemic mapping and ablation']}], 'interventions': [{'name': 'Right Ventricular Outflow Tract Posterior Septum Pacing', 'type': 'PROCEDURE', 'description': 'The Right Ventricular Outflow Tract (RVOT) posterior septum pacing is routinely performed to observe the QRS complex characteristics of the 12 lead ECG (with a focus on comparing their differences with the R-wave amplitude of spontaneous ventricular arrhythmias in the right chest (V1\\~V3) leads). When the pacing-induced R-wave amplitudes are all lower than spontaneous VAs in V1\\~V3, we predict the origin of Left Ventricular Outflow Tract (LVOT), mapping and ablation in LVOT; otherwise we predict the origin of RVOT, mapping and ablation in RVOT.If fails, go to the opposite site to do mapping and ablation. If still fails, go to distal great cardiac vein (DGCV) to do mapping and ablation.', 'armGroupLabels': ['Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group']}, {'name': 'systemic mapping and ablation', 'type': 'PROCEDURE', 'description': 'The TC or ST ablation catheter is delivered to ventricular outflow tract (VOT) to perform systemic mapping and ablation.', 'armGroupLabels': ['Convention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cheng Zheng, PhD', 'role': 'CONTACT', 'email': 'zhengcheng_wzmufey@163.com', 'phone': '86-0577-85676609'}], 'facility': "Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Cheng Zheng, PhD', 'role': 'CONTACT', 'email': 'zhengcheng_wzmufey@163.com', 'phone': '86-0577-85676609'}], 'overallOfficials': [{'name': 'Cheng Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}