Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-11-01

Brief Summary

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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).

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Detailed Description

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible consecutive patients who provide written informed consent will be randomly assigned to one of two groups: (1) an experimental group in which patients will undergo the STAR procedure (radioablation) and (2) a control group in which patients will undergo standard endocardial catheter ablation (electrophysiology) using radiofrequency current. The allocation ratio for both groups will be 1:1.

A stratified randomization method with block randomization will be applied using a centralized randomization system. The stratification factors will include sex and left ventricular ejection fraction (LVEF) (≤40% vs. \>40%). Each participant will be assigned to one of the study arms, and follow-up will be conducted in a parallel study design. Due to the distinct nature of the interventional procedures, blinding of the study will not be feasible.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Due to the distinct nature of the interventional procedures, blinding of the study is not feasible.

Study Groups

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Stereotactic Arrhythmia Radioablation (STAR) procedure

In the arm randomized to STAR (alternative experimental therapy), the procedure will involve the elimination of the sVT substrate using ionizing radiation at a dose of 25 Gy, employing highly conformal stereotactic techniques. The STAR procedure will be performed in a radiation oncology department according to a protocol developed by the research team, based on the American Association of Physicists in Medicine (AAPM) report on stereotactic radiotherapy, guidelines for radiotherapy in patients with cardiac implantable electronic devices (CIEDs), and the expert consensus on the implementation and use of STAR in treatment-resistant sVT.

Group Type EXPERIMENTAL

Stereotactic Arrhythmia Radioablation (STAR)

Intervention Type RADIATION

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.

Active Comparator: Catheter Ablation using Radiofrequency Current

In the arm randomized to CA (reference - standard therapy), the procedure will involve the elimination of the sVT substrate using energy transmitted from a generator through a catheter. The CA procedure will be performed in accordance with the expert consensus of the Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), Asia Pacific Heart Rhythm Society (APHRS), and Latin American Heart Rhythm Society (LAHRS) on ventricular arrhythmia ablation.

Group Type ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type RADIATION

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krzysztof S. Gołba, Professor

Role: STUDY_DIRECTOR

Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Ziolowa 45/47, Katowice 40-635, Poland

Danuta Łoboda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Ziolowa 45/47, Katowice 40-635, Poland