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).
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.
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.
Parallel
Stereotactic Arrhythmia Radioablation (STAR)
RadiationRadiotherapy 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.
Catheter Ablation
Procedure/SurgeryCA 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.
The burden of ventricular arrhythmias, defined as the total number of sustained ventricular tachycardia (sVT) events recorded during the 6-month observation period.
Each documented sustained ventricular tachycardia (sVT) event, captured via electrocardiogram (ECG) or intracardiac electrogram (EGM) from the CIED memory, will be subject to physician adjudication. Automatic classification of arrhythmia type, number of sVT episodes, and number of therapies performed by the CIED will be accepted only in cases where EGM recordings are unavailable, e.g., due to device memory overflow resulting from a high volume of episodes. sVT criteria: 1. Meets detection criteria in the active VT or VF zone programmed in the ICD/CRT-D and triggers an appropriate therapy; or 2. Meets detection criteria in the VT monitoring zone programmed in the ICD/CRT-D and lasts ≥ 30 seconds; or 3. Is misclassified by the ICD/CRT-D as a supraventricular tachycardia but is reclassified as sVT after physician review of the EGM; or 4. Is recorded on surface ECG with a duration of ≥ 30 seconds.
Absence of treatment-related serious adverse events (SAEs) during the 18-month follow-up period
All adverse events (AEs) assessed by the investigator as having a probable causal relationship with either the experimental therapy or standard therapy will be classified as adverse events and recorded in the study protocol. Serious Adverse Events (SAEs) Each adverse medical event meeting any of the following criteria will be classified as a Serious Adverse Event (SAE): * Results in the death of the patient. * Is life-threatening to the patient. * Results in permanent or significant disability or requires intervention to prevent permanent damage to tissues or organs. * Requires re-hospitalization or leads to an extension of the hospitalization related to the procedure by more than 24 hours.
Reduction in ventricular arrhythmia burden, measured as the percentage decrease in the mean monthly number of sustained ventricular tachycardia events during the 6-month follow-up after therapy initiation, compared to corresponding period pre-treatment
Sustained ventricular arrhythmias will be counted as stated in the Primary Outcome Measures.
Occurrence of sVT during the 18-month follow-up period
Sustained ventricular arrhythmias will be counted as stated in the Primary Outcome Measures.
Time to first occurrence of sVT during the 18-month follow-up period.
Sustained ventricular arrhythmias will be counted as stated in the Primary Outcome Measures.
Number of appropriate ICD/CRT-D therapies delivered during the 18-month follow-up period.
Appropriate therapy will be defined as: a. Therapy (ATP or shock) delivered by the ICD/CRT-D due to sVT and confirmed by physician adjudication (after excluding supraventricular arrhythmias and/or sensing abnormalities); or b. External electrical or pharmacological cardioversion following physician-confirmed documentation of sVT on ECG. Only one therapy will be counted per sVT episode. In cases where multiple therapies are delivered sequentially during a single episode, the final effective therapy leading to episode termination will be considered and counted.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
