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

Not Applicable

Recruiting

• Conditions: Refractory Ventricular Tachycardia
• Interventions: Procedure: SBRT

• Registration Number: NCT04066517
• Lead Sponsor: Centro Cardiologico Monzino

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Study Start: 2019-09-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-06-13
• Study Completion: 2025-06-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	SBRT	Non-randomized, open label clinical trial that intends to treat with SBRT 15 patients with refractory VT.

Primary Outcome Measures

Name	Time	Method
SBRT efficacy based on reduction of VT episodes during 12 month follow-up	12 months	There will be 6 week blanking period after therapy to allow for ablation effect
SBRT safety during 12 month follow-up	12 months	Serious adverse events will be defined using CTCAE v4.0 criteria.

Secondary Outcome Measures

Name	Time	Method
Total mortality	12 months
Health related quality of life	12 months	Health related quality of life for positive or negative changes based on score from SF-36 Questionnaire
Cardiac functional changes	12 months	Cardiac functional changes evaluated by echocardiography ejection fraction

Trial Locations

Locations (2)

Centro Cardiologico Monzino, IRCCS; 🇮🇹 Milano, MI, Italy

Istituto Europeo di Oncologia, IRCCS; 🇮🇹 Milano, MI, Italy