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

Recruiting
50 years of age
Both
Phase N/A

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Overview

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.

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.

Study details

Refractory Ventricular Tachycardia

NCT04066517

Centro Cardiologico Monzino

26 January 2024

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