STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

Refractory Ventricular Tachycardia Clinical Trial

— STRA-MI-VT  

Official title:

STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066517
• Other study ID #: R 918/19 - CCM968
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2019
• Est. completion date: June 13, 2025

Study information

• Verified date: September 2023
• Source: Centro Cardiologico Monzino
• Contact: Corrado Carbucicchio, MD
• Phone: +39 02 58001626
• Email: corrado.carbucicchio[@]ccfm.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 13, 2025
• Est. primary completion date: June 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractory Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Procedure:
• SBRT
Multimodal-imaging guided SBRT for VT ablation.

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino, IRCCS	Milano	MI
Italy	Istituto Europeo di Oncologia, IRCCS	Milano	MI

Sponsors (2)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Istituto Europeo di Oncologia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SBRT safety during 12 month follow-up	Serious adverse events will be defined using CTCAE v4.0 criteria.	12 months
Primary	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
Secondary	Total mortality		12 months
Secondary	Health related quality of life	Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire	12 months
Secondary	Cardiac functional changes	Cardiac functional changes evaluated by echocardiography ejection fraction	12 months