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

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

Study Overview

• Status: Recruiting
• Conditions: Refractory Ventricular Tachycardia
• Intervention / Treatment: Procedure: SBRT

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corrado Carbucicchio, MD; Phone Number: +39 02 58001626; Email: corrado.carbucicchio@ccfm.it
• Study Contact Backup: Name: Valentina Catto, PhD; Phone Number: +39 02 58002856; Email: valentina.catto@ccfm.it

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20138
      • Recruiting
      • Centro Cardiologico Monzino, IRCCS
      • Contact: Corrado Carbucicchio, MD; Phone Number: +39 02 58001626; Email: corrado.carbucicchio@ccfm.it
      • Contact: Valentina Catto, PhD; Phone Number: +39 02 58002856; Email: valentina.catto@ccfm.it
      • Principal Investigator: Corrado Carbucicchio, MD
      • Sub-Investigator: Daniele Andreini, MD, PhD
    • Milano, MI, Italy, 20141
      • Active, not recruiting
      • Istituto Europeo di Oncologia, IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label; Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.	Procedure: SBRT; Multimodal-imaging guided SBRT for VT ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Cardiac functional changes	Cardiac functional changes evaluated by echocardiography ejection fraction	12 months

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Istituto Europeo di Oncologia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Estimated): June 13, 2025
• Study Completion (Estimated): June 13, 2025

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: R 918/19 - CCM968

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No