Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-05 @ 6:39 PM
Study NCT ID:
NCT06411392
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SBRT for Ventricular Arrhythmia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of treatment', 'timeFrame': '30 days', 'description': 'Demonstration of acute (≤ 30 days) safety of non-invasive stereotactic antiarrhythmic radiotherapy for ventricular arrhythmia (STAR). The primary safety endpoint is defined as ≤ 20% rate of severe adverse events according to CTCAE v5.0 criteria'}, {'measure': 'Efficacy of treatment', 'timeFrame': '6 months', 'description': 'The efficacy endpoint is defined by the number of patients experiencing a reduction in ventricular tachycardia episodes, compared to the six-month period prior to SBRT treatment and the six-month period post- SBRT.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of changes in the left ventricular ejection fraction', 'timeFrame': '12 months', 'description': 'Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography'}, {'measure': 'Evaluation of mortality', 'timeFrame': '12 months', 'description': 'Analysis of cardiac mortality during post-treatment follow-up'}, {'measure': 'Assessment of late side effects', 'timeFrame': '12 months', 'description': 'Assessment of radiation-induced cardiac late side effects using late iodine computed tomography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stereotactic radiotherapy'], 'conditions': ['Ventricular Arrythmia']}, 'referencesModule': {'references': [{'pmid': '36072869', 'type': 'BACKGROUND', 'citation': 'Volpato G, Compagnucci P, Cipolletta L, Parisi Q, Valeri Y, Carboni L, Giovagnoni A, Dello Russo A, Casella M. Safety and Efficacy of Stereotactic Arrhythmia Radioablation for the Treatment of Ventricular Tachycardia: A Systematic Review. Front Cardiovasc Med. 2022 Aug 22;9:870001. doi: 10.3389/fcvm.2022.870001. eCollection 2022.'}, {'pmid': '34482706', 'type': 'BACKGROUND', 'citation': 'Belzile-Dugas E, Eisenberg MJ. Radiation-Induced Cardiovascular Disease: Review of an Underrecognized Pathology. J Am Heart Assoc. 2021 Sep 21;10(18):e021686. doi: 10.1161/JAHA.121.021686. Epub 2021 Sep 6.'}, {'pmid': '30586734', 'type': 'BACKGROUND', 'citation': 'Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261.'}, {'pmid': '26082532', 'type': 'BACKGROUND', 'citation': 'Loo BW Jr, Soltys SG, Wang L, Lo A, Fahimian BP, Iagaru A, Norton L, Shan X, Gardner E, Fogarty T, Maguire P, Al-Ahmad A, Zei P. Stereotactic ablative radiotherapy for the treatment of refractory cardiac ventricular arrhythmia. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):748-50. doi: 10.1161/CIRCEP.115.002765. No abstract available.'}, {'pmid': '29236642', 'type': 'RESULT', 'citation': 'Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent VTs/VES with significant burden despite guideline-directed therapy\n* Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications\n* AND lack of response or intolerance to antiarrhythmic medication\n* AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (\\<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate)\n* MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment.\n* Presence of suitability for radiation therapy with respect to SBRT\n* Age ≥ 18 years\n* Existing informed consent\n\nExclusion Criteria:\n\n* Acute myocardial infarction or percutaneous coronary intervention or heart surgery (\\<3 months before study enrollment)\n* Status post intra-thoracic pre-radiation\n* Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer\n* Advanced symptomatic heart failure (NYHA Class IV)\n* Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation)\n* Extensive myocardial scar substrate that would result in too large of a radiation volume\n* Life expectancy \\< 6 months considering all comorbidities and in the Seattle Heart Failure Model\n* Presence of a Left Ventricular Assist Device (LVAD)\n* Use of cytotoxic medications\n* Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential'}, 'identificationModule': {'nctId': 'NCT06411392', 'briefTitle': 'SBRT for Ventricular Arrhythmia', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)', 'orgStudyIdInfo': {'id': '35-439 e 22/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic Antiarrhythmic Radiotherapy', 'description': 'Stereotactic antiarrhythmic radiotherapy for refractory ventricular arrhythmia', 'interventionNames': ['Radiation: Stereotactic Antiarrhythmic Radiotherapy']}], 'interventions': [{'name': 'Stereotactic Antiarrhythmic Radiotherapy', 'type': 'RADIATION', 'description': 'Patients with ventricular tachycardia will undergo cardiac stereotactic antiarrhythmic radiotherapy with a single fraction of 25 Gy to the arrhythmia substrate, as determined by electrophysiological cardiac mapping.', 'armGroupLabels': ['Stereotactic Antiarrhythmic Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Tanja Langsenlehner, MD', 'role': 'CONTACT', 'email': 'tanja.langsenlehner@medunigraz.at', 'phone': '004331638587869'}, {'name': 'Tanja Langsenlehner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Scherr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lukas Seiß', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ursula Rohrer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Winkler, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martin Manninger-Wünscher, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Brunner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Tanja Langsenlehner, MD', 'role': 'CONTACT', 'email': 'tanja.langsenlehner@medunigraz.at', 'phone': '004331638587869'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}