Clinical Trial

SBRT in Chagas Disease Ventricular Tachycardia

Unknown Phase 1/2
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Summary
This is an observational study of 10 Chagas Disease patients with Ventricular Tachycardia that have failed prior catheter ablation or have this procedure contraindicated due to clinical status. Those patients will underwent to Stereotactic Body Radiation Therapy (SBRT) targeting the area of the heart of the VT circuits. Radioablation target will be defined based on prior ablation electroanatomical mapping, VT morphology, pre-acquired imaging (CT angiogram, Cardiac Magnetic Resonance), current imaging reconstructed and integrated to electroanatomical mapping and a EP study to define current VT morphologies. Gross targeted volume (GTV), internal targeted volume (ITV) and planning targeted volume (PTV) will be defined and calculated and a single 25Gy dose will be delivered to the PTV. Patients will be followed initially for one year and efficacy endpoint will be rate of VT recurrence, time to recurrence and VT burden. Safety endpoint will be the occurrence of any adverse effect related to SBRT.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT04984265
Lead Sponsor University of Sao Paulo General Hospital
Conditions Ventricular Tachycardia, Chagas Disease, Cardiac Arrhythmia
Enrollment 10 participants
Start Date 2021-07-14
Primary Completion 2022-07-31 (estimated)
Study Completion 2024-07-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-16