Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
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- Who runs it
- Medical University of Silesia
- Trial code
- NCT07017855
- Record updated
- 12 June 2025
- Original description
The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).Read full original descriptionShow less
The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).
Inclusion: Age ≥ 18 years at the time of enrollment; Presence of structural heart disease (SHD) of either ischemic or non-ischemic etiology; Implanted ICD or CRT-D device for primary or secondary prevention of sudden cardiac death (SCD); History of at least one endocardial CA procedure targeting a substrate of monomorphic sVT; Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT; Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management; Provision of written informed consent prior to study participation.
Exclusion: Presence of comorbidities or known risk factors for radiotherapy complications that, in the judgment of the radiation oncologist, constitute a contraindication to STAR for safety reasons; Reversible cause of sVT recurrence, particularly acute coronary syndrome (ACS), acute myocarditis, or lead-related infective endocarditis (LDIE); Myocardial infarction (MI) or cardiac surgery within the last 40 days; Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved; Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed; Active, uncontrolled malignancy and/or chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure; Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months; Systemic disease that limits the probability of survival to less than 1 year; Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies; Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved; A mobile thrombus within the left ventricle (LV); Presence of a left ventricular assist device (LVAD); Presence of comorbidities or known risk factors for CA complications that, in the judgment of the electrophysiologist, constitute a contraindication to the procedure for safety reasons; Pregnancy or breastfeeding; Other comorbidities, addictions, or social indications that, in the investigator's opinion, would preclude practical cooperation or otherwise disqualify the patient from participation in the clinical study; Refusal to participate or lack of written informed consent for study participation.