Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia (NCT07017855) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
Poland150 participantsStarted 2025-07-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕. Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies.
✕. Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved.
✕. Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.
What they're measuring
1
The burden of ventricular arrhythmias, defined as the total number of sustained ventricular tachycardia (sVT) events recorded during the 6-month observation period.
Timeframe: 6 months
2
Absence of treatment-related serious adverse events (SAEs) during the 18-month follow-up period
✕. Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.
✕. A mobile thrombus within the left ventricle (LV).
✕. Presence of a left ventricular assist device (LVAD).