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NOT YET RECRUITING

NCT07017855

Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

Sponsor: Medical University of Silesia

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-07-01

Completion Date

2028-11-01

Last Updated

2025-06-12

Healthy Volunteers

Conditions

Ventricular Tachycardia, Monomorphic Ventricular Tachycardia, Sustained Ventricular Tachycardia (VT)Ventricular Tachycardia (V-Tach)Stereotactic Body Radiation Therapy (SBRT)Stereotactic Techniques Stereotactic Radiation Cardioverter-Defibrillators, Implantable

Interventions

RADIATION

Stereotactic Arrhythmia Radioablation (STAR)

Radiotherapy Implementation: During treatment on a TrueBeam™ linear accelerator (Varian Medical Systems, Palo Alto, CA, USA), a planned radiation dose of 25 Gy will be delivered to the defined planning target volume (PTV) using highly conformal stereotactic techniques. Image-guided radiotherapy (IGRT), respiratory gating, and Triggered Tracking will be utilized, targeting the previously delineated defibrillation lead of the implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D), with position verification every 15 degrees of gantry rotation. Patient positioning will be performed using kV-kV imaging, based on pre-determined fiducial markers on the ICD/CRT-D defibrillation lead, followed by verification using gated cone-beam computed tomography (CBCT). Continuous ECG monitoring will be conducted throughout the treatment, and the patient will remain under cardiologist supervision.

PROCEDURE

Catheter Ablation

CA will be conducted in an electrophysiology laboratory and will routinely follow diagnostic procedures, including an electrophysiological study (EPS) and three-dimensional electroanatomical mapping (3D-EAM). Once sufficient data on the nature and location of the arrhythmic substrate have been obtained from the three primary mapping modules-voltage, activation, and propagation-spatial 3D-EAM maps will be integrated with a 3D left ventricular reconstruction from multislice computed tomography (MSCT) or cardiac magnetic resonance (CMR). Subsequently, ablation will be performed by delivering energy to predefined target sites identified as the arrhythmia source to close the sVT isthmus or eliminate late potentials (LPs) and/or low-amplitude ventricular activities (LAVAs). Following CA, a repeat induction attempt of sVT using programmed ventricular pacing (VP) will be conducted to verify procedural efficacy.

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.

Locations (1)

Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice

Katowice, Upper-Silesia, Poland