Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia

Launched by MARIA SKLODOWSKA-CURIE NATIONAL RESEARCH INSTITUTE OF ONCOLOGY · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for a heart condition called ventricular tachycardia (VT), which is when the heart beats too fast and can cause serious problems. The study is testing a method called non-invasive cardiac radiosurgery, which uses targeted radiation to reduce the episodes of VT. The researchers aim to see if a lower dose of radiation (20 Gy) is just as effective as a higher dose (25 Gy) used in previous treatments. This trial is currently recruiting participants aged 18 and older who have structural heart disease and have had frequent VT episodes despite other treatments.

To be eligible for the study, participants must have an implantable cardioverter defibrillator (a device that helps control heart rhythm) and have experienced VT at least three times a month. They should also have had previous treatments that didn't work, or be unable to receive certain heart procedures. Participants will have the opportunity to receive this new treatment and be monitored for its effectiveness and safety. If you or someone you know is interested in joining this study, it’s important to discuss it with a healthcare provider to determine if it's a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Patients with structural heart disease
• • Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
• • Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month
• • At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination
• • Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect).
• • Persistent recurrence of VT despite adequate pharmacotherapy.
• • Informed consent of the patient to participate in the study.
• Exclusion Criteria:
• • Premature ventricular contractions
• • Cardiac damage requiring inotropic treatment
• • Implantation of left ventricular assist device (LVAD)
• • Ventricular arrhythmia in the course of channelopathy
• • Reversible cause of VT
• • New York Heart Association (NYHA) stage IV heart failure
• • Myocardial infarction or cardiac surgery in the last 3 months.
• • Life expectancy less than 6 months
• • Polymorphic ventricular tachycardia
• • Pregnancy or breastfeeding
• • Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments).
• • Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study.
• • Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation.
• • Lack of the informed consent