Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Not Applicable

Recruiting

Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cardiac radioablation	Stereotactic Body Radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of the treatment	6 months	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)

Secondary Outcome Measures

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

Locations (2): Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
🇵🇱
Gliwice, Poland
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
🇵🇱
Katowice, Poland