Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia (SMARTER-VT)

Prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT) with reduced dose of radiation (20 Gy). The efficacy and safety outcome measures will be compared with historical control - patients treated within the SMART-VT study (NCT04642963) with a single dose of 25 Gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of VT burden.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sławomir Blamek, MD, PhD, MBA; Phone Number: +48322788052; Email: slawomir.blamek@io.gliwice.pl
• Study Contact Backup: Name: Marcin Miszczyk, MD, PhD; Email: marcin.miszczyk@io.gliwice.pl

Study Locations

• Poland
  • Gliwice, Poland, 44-102
    • Recruiting
    • Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
    • Contact: Sławomir Blamek, MD, PhD, MBA; Phone Number: +48322788052; Email: slawomir.blamek@io.gliwice.pl
    • Contact: Marcin Miszczyk, MD, PhD; Email: marcin.miszczyk@io.gliwice.pl
  • Katowice, Poland, 40-635
    • Recruiting
    • Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
    • Contact: Wojciech Wojakowski, MD, PhD; Email: welwetek@poczta.onet.pl
    • Contact: Tomasz Jadczyk, MD, PhD; Email: tomasz.jadczyk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients with structural heart disease
• Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
• Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month
• At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination
• Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect).
• Persistent recurrence of VT despite adequate pharmacotherapy.
• Informed consent of the patient to participate in the study.

Exclusion Criteria:

• Premature ventricular contractions
• Cardiac damage requiring inotropic treatment
• Implantation of left ventricular assist device (LVAD)
• Ventricular arrhythmia in the course of channelopathy
• Reversible cause of VT
• New York Heart Association (NYHA) stage IV heart failure
• Myocardial infarction or cardiac surgery in the last 3 months.
• Life expectancy less than 6 months
• Polymorphic ventricular tachycardia
• Pregnancy or breastfeeding
• Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments).
• Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study.
• Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation.
• Lack of the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac radioablation; Patients with ventricular tachycardia will undergo cardiac radiosurgery with one fraction of 20 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.	Radiation: Stereotactic Body Radiotherapy; Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM); Other Names: Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the treatment	Number of patients with a reduction of the number of ventricular tachycardia (VT) episodes by at least 50% within 6 months after the irradiation compared to the number of VT episodes within 6 months before the intervention (based on registration from ICD/CRT-D), including: the number of high-energy discharges; number of low-energy discharges for VT that was treated with stereotactic radiotherapy (STAR)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-month survival without VT episodes		6 months
Number of patients with complete elimination of ICD discharges		12 months
Number of patients with a 90% reduction in the number of ICD discharges		12 months
Number of hospitalizations due to VT episodes		12 months
Recurrences outside the irradiated area	Number of patients who developed VT with a different morphology than specified during qualification for the procedure	12 months
Early treatment safety	Number of serious adverse events (SAE) in the first 3 months after the intervention	3 months
Long term treatment safety	Number of SAE episodes within 12 months after the intervention	12 months
Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.	Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and	12 months
Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up		12 months
Change in the need for antiarrhythmic drugs		12 months
Evaluation of changes in the left ventricular ejection fraction		12 months
Evaluation of changes in the morphology of the heart in the ultrasound examination		12 months
Assessment of compliance of the results of additional imaging with the results of EAM	Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)	3 months

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
• Investigators: Principal Investigator: Sławomir Blamek, MD, PhD, MBA, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch; Principal Investigator: Wojciech Wojakwoski, MD, PhD, Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice; Study Chair: Marcin Miszczyk, MD, PhD, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: ventricular tachycardia; radioablation; stereotactic body radiotherapy (SBRT); stereotactic arrhythmia radioablation (STAR)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: KB/430-77/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be shared within the European Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM). The intention to share the anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No