Trials / Not Yet Recruiting

Not Yet RecruitingNCT07017855

Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 150 (estimated)

Sponsor: Medical University of Silesia · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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).

Detailed description

Study Objectives: To evaluate the safety and efficacy of Stereotactic Arrhythmia Radioablation (STAR) as a second-line therapy for sustained Ventricular Tachycardia (sVT) in optimally treated patients following endocardial Catheter Ablation (CA). Study Design: This study is a single-center randomized, noninferiority, head-to-head control trial comparing the efficacy and safety of two ablation methods for recurrent sVT after failing CA. Patient Population: Optimally treated patients aged ≥18 with Implantable Cardioverter-Defibrillators (ICD) in the primary or secondary prevention of sudden cardiac death (SCD), who have undergone endocardial CA and are candidates for re-ablation of recurrent symptomatic ventricular tachycardia (VT) following the 2022 European Society of Cardiology Guidelines for the management of patients with ventricular arrhythmias and the prevention of SCD. The planned size of the group is 150. The planned recruitment period is 42 months, and the observation period is 18 months. Patients will be randomly assigned to experimental and control groups for a 1:1 group size ratio. The block randomized stratification method will be used with a central randomization system. Sex and left ventricular ejection fraction (≤40% vs. \>40%) will be stratifying factors. Intervention: The intervention under investigation (experimental) will be STAR ablation. The standard intervention will be repeated endocardial radiofrequency CA. The target area for sVT ablation will be the arrhythmogenic substrate, defined by electrophysiological study (EPS) with three-dimensional electroanatomical mapping (obligatory in the standard therapy arm, optional in the STAR arm) and imaging tests (i.e., MSCT/CMR/PET-CT). The following will be integrated using dedicated computer software: 1) anatomical data-locating the arrhythmogenic scar area with channels of heterogeneous tissue-obtained using MSCT, CMR, PET-CT/SPECT, 2) three-dimensional electroanatomical maps-locating electrograms showing low peak-to-peak voltage, local abnormal ventricular activities, the sequence of myocardial activation, and critical isthmus sites for re-entrant VT, and 3) electrocardiograms detected during sinus rhythm and ventricular pacing during EPS. In the experimental arm, the obtained data will become the basis for STAR planning by a team consisting of a diagnostic cardiologist, radiologist, electrophysiologist, and radiotherapist. The obtained data will become the basis for endocardial CA planning in the control arm. Observation: Observation will include 1) clinical assessment-with the determination of the New York Heart Association functional class and exercise capacity in the 6-minute walk test (6MWT); 2) echocardiography-with the assessment of global and segmental left ventricular systolic function, mitral valve function, and the presence of fluid in the pleural and pericardial cavities; 3) parameters of pacing, sensing, lead impedance, and ventricular arrhythmic events recorded by the ICD/CRT-D; 4) QoL; and 5) procedure-related adverse events. Evaluation will be performed at 1, 3, 6, 12, and 18 months post-procedure, with endpoints assessed at 6 and 18 months. The co-primary endpoints will assess 1) treatment efficacy, defined as the number of events of monomorphic sVT over six months following the comparison procedures, and 2) treatment safety, defined as no procedure-related serious adverse events. The most important clinical parameters evaluating the effectiveness of ablation (i.e., post-procedural reduction in the sVT burden, occurrence/time to the first sVT episode, number of adequate ICD/CRT-D therapies, number of hospitalizations for arrhythmic reasons, QoL improvement) and mortality (death from any cause) were selected as secondary endpoints.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-07-01
Primary completion: 2027-05-01
Completion: 2028-11-01
First posted: 2025-06-12
Last updated: 2025-06-12

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT07017855. Inclusion in this directory is not an endorsement.