Clinical trial NCT04066517: STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Official title: STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Ventricular Tachycardia
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Istituto Europeo di Oncologia
First posted: 2019-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ICD/S-ICD recipients with refractory VT
* 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:

* Previous radiotherapy with cardiac involvement.
* 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.

Primary outcomes:
measure: SBRT safety during 12 month follow-up
timeFrame: 12 months
measure: SBRT efficacy based on reduction of VT episodes during 12 month follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Total mortality
timeFrame: 12 months
measure: Health related quality of life
timeFrame: 12 months
measure: Cardiac functional changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia, IRCCS
state: MI
Study officials:
References:
citation: 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.
citation: 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.