STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT) (NCT04066517) | Clinical Trial Compass
UnknownNot Applicable
STereotactic RadioAblation by Multimodal Imaging for VT (STRA-MI-VT)
Italy20 participantsStarted 2019-09-13
Plain-language summary
Study of multimodal-imaging guided stereotactic body radiotherapy (SBRT) for ventricular tachycardia (VT) ablation.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
SBRT safety during 12 month follow-up
Timeframe: 12 months
2
SBRT efficacy based on reduction of VT episodes during 12 month follow-up