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| Name | Class |
|---|---|
| Istituto Europeo di Oncologia | OTHER |
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Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.
STRA-MI-VT study is a spontaneous, open-label, not randomized, prospective clinical trial.
The objective of the study is to evaluate the safety and efficacy of SBRT in strictly selected patients with refractory VT.
Multimodal cardiac imaging combined with electroanatomic mapping to provide a specific patient's tailored SBRT treatment plan choosing amang different linear accelerators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Procedure | Multimodal-imaging guided SBRT for VT ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SBRT safety during 12 month follow-up | Serious adverse events will be defined using CTCAE v4.0 criteria. | 12 months |
| SBRT efficacy based on reduction of VT episodes during 12 month follow-up | There will be 6 week blanking period after therapy to allow for ablation effect | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total mortality | 12 months | |
| Health related quality of life | Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corrado Carbucicchio, MD | Contact | +39 02 58001626 | corrado.carbucicchio@ccfm.it | |
| Valentina Catto, PhD | Contact | +39 02 58002856 | valentina.catto@ccfm.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino, IRCCS | Recruiting | Milan | MI | 20138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32851578 | Background | Carbucicchio C, Jereczek-Fossa BA, Andreini D, Catto V, Piperno G, Conte E, Cattani F, Rondi E, Vigorito S, Piccolo C, Bonomi A, Gorini A, Pepa M, Mushtaq S, Fassini G, Moltrasio M, Tundo F, Marvaso G, Veglia F, Orecchia R, Tremoli E, Tondo C. STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. J Interv Card Electrophysiol. 2021 Sep;61(3):583-593. doi: 10.1007/s10840-020-00855-2. Epub 2020 Aug 27. | |
| 34609691 |
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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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No masking in this study.
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| Cardiac functional changes | Cardiac functional changes evaluated by echocardiography ejection fraction | 12 months |
| Istituto Europeo di Oncologia, IRCCS | Active, not recruiting | Milan | MI | 20141 | Italy |
| Background |
| Carbucicchio C, Andreini D, Piperno G, Catto V, Conte E, Cattani F, Bonomi A, Rondi E, Piccolo C, Vigorito S, Ferrari A, Pepa M, Giuliani M, Mushtaq S, Scara A, Calo L, Gorini A, Veglia F, Pontone G, Pepi M, Tremoli E, Orecchia R, Pompilio G, Tondo C, Jereczek-Fossa BA. Stereotactic radioablation for the treatment of ventricular tachycardia: preliminary data and insights from the STRA-MI-VT phase Ib/II study. J Interv Card Electrophysiol. 2021 Nov;62(2):427-439. doi: 10.1007/s10840-021-01060-5. Epub 2021 Oct 5. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |