Ventricular Tachycardia, MonomorphicSTAR-4VTNCT07017855
Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
A study testing Stereotactic Arrhythmia Radioablation (STAR) and Catheter Ablation in people with Ventricular Tachycardia, Monomorphic and Ventricular Tachycardia, Sustained, run by Medical University of Silesia at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia, Sustained, Ventricular Tachycardia (VT)
- What is being tested?
- Stereotactic Arrhythmia Radioablation (STAR) and Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.
- Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management.
- Provision of written informed consent prior to study participation.
Who cannot join
- 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.
- Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.
- Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.
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- A mobile thrombus within the left ventricle (LV).
- Presence of a left ventricular assist device (LVAD).
- 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.
- Active, uncontrolled malignancy and/or chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure.
- Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months.
- 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.
- Pregnancy or breastfeeding.
- Systemic disease that limits the probability of survival to less than 1 year
- 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.
- Refusal to participate or lack of written informed consent for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Katowice, Upper-Silesia, 40-635
Krzysztof S. Gołba, Professor, +48 32 359 88 90, kgolba@sum.edu.pl
Danuta Łoboda, MD, PhD, +48 32 359 88 93, dloboda@sum.edu.pl
About this study
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).
Read the 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
- Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia, Sustained, Ventricular Tachycardia (VT), Ventricular Tachycardia (V-Tach), Stereotactic Body Radiation Therapy (SBRT), Stereotactic Techniques
- Being tested
- Stereotactic Arrhythmia Radioablation (STAR), Catheter Ablation
- Keywords
- Ventricular Tachycardia, VT, Stereotactic Arrhythmia Radioablation, STAR, Implanted Cardioverter-Defibrillator, ICD
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Arrhythmia Radioablation (STAR)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.
Catheter AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Arrhythmia Radioablation (STAR) procedure | Experimental | 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. Receives: Radiation: Stereotactic Arrhythmia Radioablation (STAR) |
| Active Comparator: Catheter Ablation using Radiofrequency Current | Active comparator | 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. Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Meets detection criteria in the active VT or VF zone programmed in the ICD/CRT-D and triggers an appropriate therapy; or
- Meets detection criteria in the VT monitoring zone programmed in the ICD/CRT-D and lasts ≥ 30 seconds; or
- Is misclassified by the ICD/CRT-D as a supraventricular tachycardia but is reclassified as sVT after physician review of the EGM; or
- Is recorded on surface ECG with a duration of ≥ 30 seconds.
Measured: 6 months
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.
Measured: 18 months
Secondary outcomes (7)
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.
Measured: 6 months
Occurrence of sVT during the 18-month follow-up period
Sustained ventricular arrhythmias will be counted as stated in the Primary Outcome Measures.
Measured: 18 months
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.
Measured: 18 months
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.
Measured: 18 months
Number of hospitalizations due to arrhythmic causes during the 18-month follow-up period.
Number of hospitalizations due to arrhythmic causes during the 18-month follow-up period.
Measured: 18 months
All-cause mortality during the 18-month follow-up period.
All-cause mortality during the 18-month follow-up period.
Measured: 18 months
Improvement in quality of life assessed using the Polish version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire during the 18-month follow-up period.
Improvement in quality of life assessed using the Polish version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire during the 18-month follow-up period.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventricular Tachycardia, MonomorphicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof S. Gołba, Professor, Study director, Department of Electrocardiology, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Ziolowa 45/47, Katowice 40-635, PolandDanuta Łoboda, MD, PhD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017855
- Sponsor's protocol ID
- 2023/ABM/01/00031
- Acronym
- STAR-4VT
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to General Data Protection Regulation (GDPR) - EU regulation on personal data protection (Regulation (EU) 2016/679).
Publications
Miszczyk M, Sajdok M, Bednarek J, Latusek T, Wojakowski W, Tomasik B, Wita K, Jadczyk T, Kurzelowski R, Drzewiecka A, Cybulska M, Gardas R, Jarosinski G, Dolla L, Grzadziel A, Zub K, Bekman A, Kaminiow K, Kozub A, Golba KS, Blamek S. Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. Radiother Oncol. 2023 Nov;188:109857. doi: 10.1016/j.radonc.2023.109857. Epub 2023 Aug 18.
PubMed 37597807Miszczyk M, Jadczyk T, Golba K, Wojakowski W, Wita K, Bednarek J, Blamek S. Clinical Evidence behind Stereotactic Radiotherapy for the Treatment of Ventricular Tachycardia (STAR)-A Comprehensive Review. J Clin Med. 2021 Mar 17;10(6):1238. doi: 10.3390/jcm10061238.
PubMed 33802802
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT07017855
- Acronym / sponsor ID
- STAR-4VT / 2023/ABM/01/00031
- Conditions
- Ventricular Tachycardia, Monomorphic, Ventricular Tachycardia, Sustained, Ventricular Tachycardia (VT), Ventricular Tachycardia (V-Tach), Stereotactic Body Radiation Therapy (SBRT), Stereotactic Techniques
- Keywords
- Ventricular Tachycardia, VT, Stereotactic Arrhythmia Radioablation, STAR, Implanted Cardioverter-Defibrillator, ICD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Arrhythmia Radioablation (STAR) procedure | Experimental | Radiation: Stereotactic Arrhythmia Radioablation (STAR)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. |
| Active Comparator: Catheter Ablation using Radiofrequency Current | Active comparator | Procedure: Catheter AblationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.
Key exclusion criteria (16 listed)
- 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.
- Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Stereotactic Arrhythmia Radioablation (STAR) procedure |
| Catheter AblationCA 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. | Procedure or surgery | Active Comparator: Catheter Ablation using Radiofrequency Current |
Primary outcome
The burden of ventricular arrhythmias, defined as the total number of sustained ventricular tachycardia (sVT) events recorded during the 6-month observation period.
Time frame: 6 months
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
Time frame: 18 months
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.
7 secondary outcomes
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
Time frame: 6 months
Occurrence of sVT during the 18-month follow-up period
Time frame: 18 months
Time to first occurrence of sVT during the 18-month follow-up period.
Time frame: 18 months
Number of appropriate ICD/CRT-D therapies delivered during the 18-month follow-up period.
Time frame: 18 months
Number of hospitalizations due to arrhythmic causes during the 18-month follow-up period.
Time frame: 18 months
All-cause mortality during the 18-month follow-up period.
Time frame: 18 months
Improvement in quality of life assessed using the Polish version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire during the 18-month follow-up period.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 37597807Miszczyk M, Sajdok M, Bednarek J, Latusek T, Wojakowski W, Tomasik B, Wita K, Jadczyk T, Kurzelowski R, Drzewiecka A, Cybulska M, Gardas R, Jarosinski G, Dolla L, Grzadziel A, Zub K, Bekman A, Kaminiow K, Kozub A, Golba KS, Blamek S. Stereotactic management of arrhythmia - radiosurgery in treatment of ventricular tachycardia (SMART-VT). Results of a prospective safety trial. Radiother Oncol. 2023 Nov;188:109857. doi: 10.1016/j.radonc.2023.109857. Epub 2023 Aug 18.
- Background: PubMed 33802802Miszczyk M, Jadczyk T, Golba K, Wojakowski W, Wita K, Bednarek J, Blamek S. Clinical Evidence behind Stereotactic Radiotherapy for the Treatment of Ventricular Tachycardia (STAR)-A Comprehensive Review. J Clin Med. 2021 Mar 17;10(6):1238. doi: 10.3390/jcm10061238.
- Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, U.S. Department of Health and Human Services. Published: November 27, 2017Link provided by the sponsor.
- NCI Guidelines For Investigators: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AN D CIP) AND DCP inds AND idesLink provided by the sponsor.
- Miszczyk M, Jadczyk T, Tomasik B, et al. Stereotactic management of arrhythmia radiosurgery in treatment of ventricular tachycardia (SMART VT) clinical trial protocol and study rationale. OncoReview 2020; 10(4): 123 129.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Due to General Data Protection Regulation (GDPR) - EU regulation on personal data protection (Regulation (EU) 2016/679).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krzysztof S. Gołba, Professor 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 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Arrhythmia Radioablation (STAR) and Catheter Ablation in people with Ventricular Tachycardia, Monomorphic and Ventricular Tachycardia, Sustained, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krzysztof S. Gołba, Professor (+48 32 359 89 90, kgolba@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The burden of ventricular arrhythmias, defined as the total number of sustained ventricular tachycardia (sVT) events recorded during the 6-month observation period. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.