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The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.
By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,
Participation in the study does not involve any expense for the patient or any compensation.
Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.
The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory ventricular tachycardia patients | Experimental | Patients with refractory VT as defined above
They will have an initial assessment to verify that condition met the inclusion criteria required for participation, such as.It will be performed
They will undergo stereotactic treatment on the arrhythmogenic cardiac site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | SBRT ( 25 Gy single fractions at isodose 80%) on the area responsible of ventricular tachicardia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of VT episodes | The primary endpoint will be The reduction in VT episodes compared with the pre-treatment period as reported by ICD assessment at follow-up within 12 months after enrollment. The number of VT episodes during the last 3 months before treatment will be compared with the number of VT episodes recorded in a 3-month period after the 'blanking period' thus during the 4th, 5th and 6th months. | Starting from the week after treatment until 6 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient management | Reduction in VT episodes compared with the pre-treatment period as reported by ICD query in the shortest observational period. In more detail: the number of VT episodes in the last month before treatment will be compared with the number of VT episodes recorded in the third (3rd) month after treatment. | Starting from the week after treatment until 6 months later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Cellini | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Universitario Agostino Gemelli IRCSS | Rome | RM | 00168 | 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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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| Change in the dosage of antiarrhythmic drugs | Total reduction/suspension of antiarrhythmic drugs compared with baseline (before radiotherapy). | Starting from the week after treatment until 6 months later |
| Change in cardiac parameters | Improvement in cardiac parameters compared with baseline: LVEF, left ventricular diastolic volume | Starting from the week after treatment until 6 months later |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |