Hypofractionated RADIOtherapy to the STellate ganglia for ventricular ARrhythmia
Arrhythmia
Current interventions as of 10/10/2024: Participation will involve a total of 9 visits over the course of 9 months. This includes the initial screening and planning scans, a full course of Image-guided hypofractionated radiotherapy and 6 months follow-up after completion of radiotherapy. The first study visit is a screening visit at the John Radcliffe Hospital. Here the study procedures are discussed, and a screening consent is obtained from participants. At this visit a baseline cardiovascular examination is performed and baseline blood tests will be taken. Patients will be given a questionnaire to assess their baseline quality of life. We will review patients' ICD data to establish arrhythmia burden over the preceding 6 months and baseline heart rate characteristics. On this visit, all participants will undergo a screening MRI scan at OCMR to assess for imaging artefact and ability to tolerate MRI scanning. If this is successful they will then be invited to formally enter the study. If the results of the screening visit indicate patients are not eligible or safe to continue with our study, they will exit at this point. The next study visit will be at a radiotherapy facility in Oxford. During this visit participants will meet the radiotherapy team who will be planning and carrying out their radiotherapy treatment. During this visit participants will be counselled about what to expect from their radiotherapy treatment and possible side effects. If patients are still willing to continue with the study informed written consent will be obtained for patients to formally enter the study. Importantly all relevant risks would already have been covered in the initial screening consent. However, we still feel a dedicated visit with the radiotherapy team is important, to ensure patients have fully understood the process and any potential risks involved before formally entering the study. We have allocated a separate visit for this to allow patients a further opportunity to
1. Male or Female, aged at least 18 years old. 2. Known diagnosis of structural heart disease defined as any patient with impaired left ventricular ejection fraction (less than 55%) due to any cause including; ischaemic cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy or Arrhythmogenic cardiomyopathy. 3. CMR compatible ICD device implanted a minimum of 6 months ago, under follow-up at Oxford University Hospitals NHS Foundation Trust. 4. Experienced more than one appropriate ICD therapy (shocks or anti-tachycardia pacing) for ventricular arrhythmia in the last 6 months 5. Established on optimal guideline-based medical therapy for heart failure
General Exclusion Criteria: 1. Device radiation dose or nearby organs at risk exceeding the limit for low-risk radiotherapy as defined by the UK Consensus and AAPM 2019 guidelines 2. Female patients who are pregnant, lactating or planning pregnancy during the study period 3. Patients who are terminally ill, inappropriate for intervention, or unable to consent 4. Any impediment to communication which, in the opinion of the investigator, might prevent the investigator communicating effectively with the patient during the study which could cause a safety or reliability concern. 5. Any other condition which, in the opinion of the investigator, might affect the safety of the participant or reduce the reliability of the study results 6. Involvement in any other research project where the procedures would affect the outcomes of this study. Additional Exclusion Criteria for Participants Undergoing MRI Studies: 7. Metal clips or metallic foreign body 8. Prior injury to the eye involving fragments of metal 9. Prior shrapnel injuries 10. Any other metallic or electronic implants affected by the magnetic field 11. History of severe claustrophobia 12. Severe liver damage, TB, pulmonary disease, anaemia, blood coagulation disorders