Non-invasive cardiac radiosurgery for treating ventricular tachycardia
Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia
This study is testing a new non-invasive radiation treatment for people with ventricular tachycardia to see if a lower dose can still effectively reduce their heart rhythm problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 2 sites (Gliwice and 1 other locations) |
| Trial ID | NCT05913375 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of a non-invasive cardiac radiosurgery technique called stereotactic body radiotherapy (SBRT) for patients suffering from ventricular tachycardia (VT). It aims to evaluate whether a reduced radiation dose of 20 Gy is as effective as the previously used 25 Gy in reducing the burden of VT. The study will compare outcomes with historical controls from the SMART-VT study to assess the potential benefits of this lower dose approach. Participants will be monitored for their response to treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates include adults with structural heart disease and recurrent symptomatic ventricular tachycardia despite previous treatments.
Not a fit: Patients with premature ventricular contractions or those requiring inotropic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and effective option for patients with recurrent ventricular tachycardia who have not responded to traditional therapies.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific method is being evaluated for the first time with a reduced radiation dose.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gliwice and 1 other locations
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch — Gliwice, Poland (Recruiting)
- Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia — Katowice, Poland (Recruiting)
Study contacts
- Principal investigator: Sławomir Blamek, MD, PhD, MBA — Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
- Study coordinator: Sławomir Blamek, MD, PhD, MBA
- Email: slawomir.blamek@io.gliwice.pl
- Phone: +48322788052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.