Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:24 AM
Study NCT ID:
NCT05964660
Status:
RECRUITING
Last Update Posted:
2024-08-29
First Post:
2023-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization', 'timeFrame': '1 month after complete data collection', 'description': 'The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the ventricular arrhythmogenic substrate in patients exhibiting ventricular arrhythmias.'}, {'measure': 'Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy', 'timeFrame': '1 month after complete data collection', 'description': 'The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the planning target volume for stereotactic arrhythmia radioablation therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventricular arrhythmia', 'Ventricular tachycardia', 'Stereotactic arrhythmia radioablation', 'Artificial intelligence', 'Motion management', 'Motion integration'], 'conditions': ['Ventricular Arrythmia']}, 'descriptionModule': {'briefSummary': 'Prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia radioablation.', 'detailedDescription': 'This is a prospective, observational, single center, pilot study. Data from preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography of patients receiving catheter ablation for ventricular arrhythmia will be analyzed by means of artificial intelligence in order to better characterize the ventricular arrhythmogenic substrate and to improve the definition methods of the planning target volume during the stereotactic arrhythmia radioablation therapy by integrating the motion data into volume demarcation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 20 patients with indication for catheter ablation of ventricular arrhythmia (VA) (ventricular tachycardia (VT), ventricular fibrillation (VF), premature ventricular contraction (PVC)) and for preprocedural contract-enhanced cardiac computed tomography (CT) for cardiac structure characterization will be prospectively enrolled in the study. The therapeutic approach follows the current clinical standard.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Indication for catheter ablation of ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions)\n* Indication for preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization\n\nExclusion Criteria:\n\n* Platelet count \\< 100,000 cells/mm3\n* BMI \\> 45 kg/m2 or \\< 18 kg/m2'}, 'identificationModule': {'nctId': 'NCT05964660', 'acronym': 'MATRIX-VT', 'briefTitle': 'Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'New 3D-echocardiography-based Motion Integration and mAnagement for subsTrate characteRisation and Stereotactic Arrhythmia radIoablation tX in Ventricular Tachycardias- the MATRIX-VT Study', 'orgStudyIdInfo': {'id': 'MATRIX-VT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VT Patients', 'description': 'Patients with indication for catheter ablation of ventricular arrhythmia and preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Roland R Tilz, Prof. Dr.med', 'role': 'CONTACT', 'email': 'roland.tilz@uksh.de', 'phone': '0049451500', 'phoneExt': '44533'}, {'name': 'Mirco Kuechler', 'role': 'CONTACT', 'email': 'mirco.kuechler@uksh.de', 'phone': '0049451500', 'phoneExt': '77075'}], 'facility': 'Klinik für Rhythmologie', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Robotics and Cognitive Systems, University of Luebeck, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med.univ.', 'investigatorFullName': 'Prof. Roland Richard Tilz', 'investigatorAffiliation': 'University of Luebeck'}}}}