Cardiac RadiothErapy for VEntricular Tachycardia

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with ventricular tachycardia (VT), a serious heart rhythm problem that does not respond well to standard medications. The study aims to see if a method called stereotactic body radiotherapy (SBRT) can safely and effectively treat VT in patients who have not had success with other treatments, such as antiarrhythmic drugs or catheter ablation. Participants in the trial will receive a single dose of radiation targeted at the area of the heart causing the VT, based on detailed mapping of their heart activity.

To be eligible for this trial, patients must be at least 18 years old, have a structural heart condition, and have an implantable cardioverter defibrillator (ICD) that has been activated due to their VT. They should have already tried at least one antiarrhythmic medication and undergone at least one catheter ablation that did not work. Patients will be asked to fill out a questionnaire about their quality of life before and after the treatment to help researchers understand the treatment's impact. While participating in this trial has the potential to help manage VT, there may be risks involved, including possible side effects from the radiation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥ 18 years
• • Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)
• • Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)
• • The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement
• • Patient must have failed or become intolerant to at least one antiarrhythmic medication
• • Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location
• • Ability to give a written informed consent and willingness to return for follow-up
• Exclusion Criteria:
• • Pregnancy or breastfeeding
• • Lack of evidence of a myocardial scar triggering the VT
• • Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
• • Advanced symptomatic heart failure defined as NYHA Class IV heart failure
• • Previous radiotherapy with cardiac involvement
• • Life expectancy \< 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
• • Any condition that is deemed a contraindication in the judgment of the investigators