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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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).