NCT05913375RecruitingNot Applicable
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Maria Sklodowska-Curie National Research Institute of Oncology2 sites in 1 country20 target enrollmentStarted: July 24, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Efficacy of the treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cardiac radioablation
Experimental
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.
Intervention: Stereotactic Body Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Efficacy of the treatment
Time Frame: 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 Outcomes
- Early treatment safety(3 months)
- Number of hospitalizations due to VT episodes(12 months)
- Long term treatment safety(12 months)
- Recurrences outside the irradiated area(12 months)
- 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)
- Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.(12 months)
- 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)
Investigators
Study Sites (2)
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