Ventricular Tachycardia
Conditions
Keywords
Ventricular Tachycardia, Ablation, Noninvasive, Stereotactic Body Radiation Therapy, Radiosurgery, Substrate Ablation
Brief summary
Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).
Detailed description
The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.
Interventions
RADIATIONCardiac Radiosurgery
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with structural heart disease and implantable cardioverter defibrillator (ICD) * Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment. * At least one episode of monomorphic VT registered in electrophysiological examination. * Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment). * Patient must be able to understand and be willing to sign a written informed consent document.
Exclusion criteria
* Heart failure requiring inotropic treatment or mechanical assistance * Arrhythmia due to cardiac channelopathy * Reversible source of arrhythmia * NYHA (New York Heart Association) stage IV hearth failure * Hearth infarction or cardiac surgery in last 3 months * Life expectancy \<6 months * Polymorphic VT * Pregnancy * Prior radiotherapy to the thoracic region (relative contraindication) * Failure to induce VT during electrophysiological examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity evaluated using CTCAE v5.0 scale | 3 months | The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical markers of cardiac injury | 24 months | Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) to assess the early cardiac muscle damage and changes in severity of congestive heart failure. |
| Late toxicity and mortality | 24 months | Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death. |
| Efficacy of the treatment | 24 months | Reduction of VT burden, ICD shocks and improvement in life quality as described by SF-36 (The Short Form Health Survey) v2 questionnaire. f eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. |
| Cardiac injury | 24 months | Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies. |
| Target volume delineation | 24 months | Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods) |
| Anti-arrhythmic drugs uptake | 24 months | Changes in the anti-arrhythmic medications over time after treatment. |
Countries
Poland
Outcome results
None listed