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Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Radiosurgery | Experimental | Patients with ventricular tachycardia will undergo a non-invasive cardiac radiosurgery using one fraction of 25 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Radiosurgery | Radiation | Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity evaluated using CTCAE v5.0 scale | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sławomir Blamek, dr hab. n. med. | Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO) | Principal Investigator |
| Wojciech Wojakowski, prof. dr hab. n. med. | Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice | Principal Investigator |
| Marcin Miszczyk, dr n. med. | Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch | Gliwice | Silesian Voivodeship | 44-102 | Poland | ||
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The data will be shared within the European STOPSTORM consortium, which is dedicated to the development of cardiac radiosurgery for the treatment of ventricular tachycardia. The intention to share anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 24 months |
| Biochemical markers of cardiac injury | 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. | 24 months |
| Late toxicity and mortality | Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death. | 24 months |
| Anti-arrhythmic drugs uptake | Changes in the anti-arrhythmic medications over time after treatment. | 24 months |
| Cardiac injury | Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies. | 24 months |
| Target volume delineation | Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods) | 24 months |
| Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice |
| Katowice |
| Poland |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |