STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
NCT ID: NCT04066517
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-09-13
2025-06-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label
Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.
SBRT
Multimodal-imaging guided SBRT for VT ablation.
Interventions
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SBRT
Multimodal-imaging guided SBRT for VT ablation.
Eligibility Criteria
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Inclusion Criteria
* Not eligible for conventional catheter ablation or -in alternative- that have undergone failing conventional catheter ablation attempts, refusing surgery for the treatment of the arrhythmia.
* LVEF ≥ 20%.
* Age ≥ 50 years.
* Signed an IRB approved written informed consent document.
Exclusion Criteria
* Pregnancy or breastfeeding.
* Active myocardial ischemia.
* Acute revascularation in the past 120 days.
* Acute hemodynamic instability (cardiogenic shock/NYHA IV).
* Serious disease with presumed life expectancy less than 12 months.
* Any condition that is deemed a contraindication in the judgment of the investigators.
50 Years
ALL
No
Sponsors
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Istituto Europeo di Oncologia
OTHER
Centro Cardiologico Monzino
OTHER
Responsible Party
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Corrado Carbucicchio
Head of Ventricular Intensive Care Unit
Locations
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Centro Cardiologico Monzino, IRCCS
Milan, MI, Italy
Istituto Europeo di Oncologia, IRCCS
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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R 918/19 - CCM968
Identifier Type: -
Identifier Source: org_study_id
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