Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

NCT07017855 | Not Yet Recruiting

• 1 other identifier: 2023/ABM/01/00031
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

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

Keywords

Ventricular Tachycardia; VT; Stereotactic Arrhythmia Radioablation; STAR; Implanted Cardioverter-Defibrillator; ICD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  6 months

• Occurrence of sVT during the 18-month follow-up period

  18 months

• Time to first occurrence of sVT during the 18-month follow-up period.

  18 months

• Number of appropriate ICD/CRT-D therapies delivered during the 18-month follow-up period.

  18 months

• Number of hospitalizations due to arrhythmic causes during the 18-month follow-up period.

  18 months

Study Arms (2)

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.

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.

Procedure: Catheter Ablation

Interventions

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.

Stereotactic Arrhythmia Radioablation (STAR) procedure

Catheter Ablation 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.

Active Comparator: Catheter Ablation using Radiofrequency Current

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

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

Katowice, Upper-Silesia, 40-635, Poland

Location

Related Publications (2)

• 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.

  PMID: 37597807 BACKGROUND

• Miszczyk 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.

  PMID: 33802802 BACKGROUND

Related Links

• Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, U.S. Department of Health and Human Services. Published: November 27, 2017
• NCI Guidelines For Investigators: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AN D CIP) AND DCP inds AND ides
• 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.

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Krzysztof S. Gołba, Professor

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

  STUDY DIRECTOR

• Danuta Łoboda, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof S. Gołba, Professor

CONTACT

+48 32 359 89 90; kgolba@sum.edu.pl

Danuta Łoboda, MD, PhD

CONTACT

+48 32 359 88 93; dloboda@sum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the distinct nature of the interventional procedures, blinding of the study is not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 12, 2025

Record last verified: 2025-03

Locations

PL (1)