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| Name | Class |
|---|---|
| Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment | 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:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Six-month survival without VT episodes | 6 months | |
| Number of patients with complete elimination of ICD discharges | 12 months | |
| Number of patients with a 90% reduction in the number of ICD discharges |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SÅ‚awomir Blamek, MD, PhD, MBA | Contact | +48322788052 | slawomir.blamek@io.gliwice.pl | |
| Marcin Miszczyk, MD, PhD | Contact | marcin.miszczyk@io.gliwice.pl |
| Name | Affiliation | Role |
|---|---|---|
| Sławomir Blamek, MD, PhD, MBA | Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch | Principal Investigator |
| Wojciech Wojakwoski, MD, PhD | Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch | Recruiting | Gliwice | 44-102 | Poland |
The data will be shared within the European Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM). The intention to share the anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.
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|
| 12 months |
| Number of hospitalizations due to VT episodes | 12 months |
| Recurrences outside the irradiated area | Number of patients who developed VT with a different morphology than specified during qualification for the procedure | 12 months |
| Early treatment safety | Number of serious adverse events (SAE) in the first 3 months after the intervention | 3 months |
| Long term treatment safety | Number of SAE episodes within 12 months after the intervention | 12 months |
| Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage. | Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and | 12 months |
| Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up | 12 months |
| Change in the need for antiarrhythmic drugs | 12 months |
| Evaluation of changes in the left ventricular ejection fraction | 12 months |
| Evaluation of changes in the morphology of the heart in the ultrasound examination | 12 months |
| Assessment of compliance of the results of additional imaging with the results of EAM | Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable) | 3 months |
| Principal Investigator |
| Marcin Miszczyk, MD, PhD | Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch | Study Chair |
| Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia | Recruiting | Katowice | 40-635 | Poland |
|
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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