Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

Launched by MEDICAL UNIVERSITY OF SILESIA · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for patients who experience recurrent episodes of a heart rhythm problem known as sustained ventricular tachycardia (sVT). This condition can be serious and is often treated with a procedure called catheter ablation. However, if this treatment doesn’t work, the trial will compare the effectiveness and safety of repeating the catheter ablation to a newer approach called Stereotactic Arrhythmia Radioablation (STAR). Both treatments aim to help patients who have an implanted device (like an ICD) that helps prevent sudden heart issues.

To be eligible for this trial, participants must be at least 18 years old and have a history of heart disease, along with having had a previous catheter ablation procedure. They'll also need to have experienced at least one significant episode of sVT. However, there are some criteria that would exclude individuals from participating, such as having certain recent heart conditions or other serious health issues. If eligible, participants can expect close monitoring and care throughout the study as researchers gather data on how well each treatment works in reducing their symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years at the time of enrollment.
• • 2. Presence of structural heart disease (SHD) of either ischemic or non-ischemic etiology.
• • 3. Implanted ICD or CRT-D device for primary or secondary prevention of sudden cardiac death (SCD).
• • 4. History of at least one endocardial CA procedure targeting a substrate of monomorphic sVT.
• • 5. Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.
• • 6. Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management.
• • 7. Provision of written informed consent prior to study participation.
• Exclusion Criteria:
• • 1. Reversible cause of sVT recurrence, particularly acute coronary syndrome (ACS), acute myocarditis, or lead-related infective endocarditis (LDIE).
• • 2. Myocardial infarction (MI) or cardiac surgery within the last 40 days.
• • 3. Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies.
• • 4. Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved.
• • 5. Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.
• • 6. Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.
• • 7. A mobile thrombus within the left ventricle (LV).
• • 8. Presence of a left ventricular assist device (LVAD).
• • 9. 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.
• • 10. Active, uncontrolled malignancy and/or chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure.
• • 11. Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months.
• • 12. 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.
• • 13. Pregnancy or breastfeeding.
• • 14. Systemic disease that limits the probability of survival to less than 1 year
• • 15. 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.
• • 16. Refusal to participate or lack of written informed consent for study participation.