Ventricular Arrythmia Clinical Trial
Official title:
Stereotactic Antiarrhythmic Radiotherapy for Ventricular Arrhythmia in Austria (Austrian STAR)
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | February 2027 |
Est. primary completion date | February 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Recurrent VTs/VES with significant burden despite guideline-directed therapy - Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications - AND lack of response or intolerance to antiarrhythmic medication - 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) - 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. - Presence of suitability for radiation therapy with respect to SBRT - Age = 18 years - Existing informed consent Exclusion Criteria: - Acute myocardial infarction or percutaneous coronary intervention or heart surgery (<3 months before study enrollment) - Status post intra-thoracic pre-radiation - Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer - Advanced symptomatic heart failure (NYHA Class IV) - Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation) - Extensive myocardial scar substrate that would result in too large of a radiation volume - Life expectancy < 6 months considering all comorbidities and in the Seattle Heart Failure Model - Presence of a Left Ventricular Assist Device (LVAD) - Use of cytotoxic medications - Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Graz | Graz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
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. Erratum In: J Am Heart Assoc. 2023 May 16;12(10):e027687. — View 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: — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of treatment | 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 | 30 days | |
Primary | Efficacy of treatment | 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. | 6 months | |
Secondary | Evaluation of changes in the left ventricular ejection fraction | Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography | 12 months | |
Secondary | Evaluation of mortality | Analysis of cardiac mortality during post-treatment follow-up | 12 months | |
Secondary | Assessment of late side effects | Assessment of radiation-induced cardiac late side effects using late iodine computed tomography | 12 months |
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