Actively Recruiting
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2023-10-19
20
Participants Needed
2
Research Sites
144 weeks
Total Duration
On this page
Sponsors
M
Maria Sklodowska-Curie National Research Institute of Oncology
Lead Sponsor
L
Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years or older
- Diagnosed with structural heart disease
- Have an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
- Clinically symptomatic ventricular arrhythmia with at least 3 episodes of ventricular tachycardia per month despite treatment
- At least one episode of monomorphic ventricular tachycardia recorded during electrophysiological examination
- Recurrent ventricular tachycardia after at least one failed percutaneous ablation attempt or disqualification from this treatment
- Persistent recurrence of ventricular tachycardia despite adequate medication
- Able and willing to give informed consent to participate in the study
You will not qualify if you...
- Premature ventricular contractions
- Cardiac damage requiring inotropic treatment
- Implantation of left ventricular assist device (LVAD)
- Ventricular arrhythmia caused by channelopathy
- Reversible cause of ventricular tachycardia
- New York Heart Association (NYHA) stage IV heart failure
- Myocardial infarction or cardiac surgery within the last 3 months
- Life expectancy less than 6 months
- Polymorphic ventricular tachycardia
- Pregnancy or breastfeeding
- Substrate location preventing safe radiotherapy (due to critical organ location or prior radiotherapy dose)
- Active systemic, pulmonary, or pericardial inflammatory process requiring treatment in past 6 months, except stable sarcoidosis
- Active uncontrolled cancer or chemo/immunotherapy within the past month or planned within one month after treatment
- Lack of informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland, 44-102
Actively Recruiting
2
Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
Katowice, Poland, 40-635
Actively Recruiting
Research Team
S
Sławomir Blamek, MD, PhD, MBA
CONTACT
M
Marcin Miszczyk, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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