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| Name | Class |
|---|---|
| Azienda USL Reggio Emilia - IRCCS | OTHER_GOV |
| IRCCS Sacro Cuore Don Calabria di Negrar | OTHER |
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
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This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STereotactic Arhythmia Radioablation (STAR) | Experimental | Patients fulfilling the inclusion and exclusion criteria will undergo (or already underwent) a single-session 25 Gy STAR for the treatment of refractory monomorphic VT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STereotactic Arhythmia Radioablation (STAR) | Radiation | STereotactic Arhythmia Radioablation (STAR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| VT storm and incessant VT | 6-month survival free from VT storm (3 or more episodes or sustained or treated VT within 24 hours) and incessant VT (binary endpoint), including an initial blanking period of 8 weeks. | 6 months |
| adverse events | : measured by registered adverse events using the CTCAE v5 system, 'early' (up to 30 days), 'intermediate' (30-90 days), and 'late' (>90 days after treatment). The extensive mandatory and optional follow-up examinations provide the basis for detecting these adverse events. | 33 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaetano Maria De Ferrari, MD | Contact | +390116336022 | gaetanomariadeferrari@unito.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin | Recruiting | Turin | Italy |
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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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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |