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

Launched by CENTRO CARDIOLOGICO MONZINO · Aug 21, 2019

Keywords

ClinConnect Summary

The STRA-MI-VT trial is studying a new approach to treat a heart condition called refractory ventricular tachycardia (VT), which is when the heart beats too fast and can cause serious problems. This study is testing a type of treatment called stereotactic body radiotherapy (SBRT), guided by advanced imaging techniques, to see if it can safely and effectively help patients who have not responded to standard treatments.

To be eligible for this trial, participants need to have an implantable cardioverter-defibrillator (ICD) and be at least 50 years old, with a heart function that is still somewhat adequate. They should either not be suitable for traditional catheter ablation or have tried it without success. Participants will undergo careful monitoring and receive the SBRT treatment, with the aim of reducing their VT episodes. It’s important to note that individuals with certain conditions, like recent heart issues or serious health problems, won’t be able to participate. Overall, this trial offers hope for patients looking for alternative treatment options for their heart rhythm issues.

Gender

ALL

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.