MR guided radiotherapy for ventricular arrhythmias

Not Applicable

Conditions: Arrhythmia
Circulatory System

Registration Number: ISRCTN49861434

Lead Sponsor: niversity of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
During all MR guided radiotherapy sessions and monitoring visits up to 6 months post radiotherapy:<br>1. Treatment related serious adverse events (SAEs) defined as any grade 3 toxicity requiring hospitalization or any grade 4 to 5 toxicity as defined by the common terminology criteria for adverse events<br>2. Treatment related side effects based on patient symptom questionnaires and clinical examination during study visits

Secondary Outcome Measures

Name	Time	Method
1.Assess the feasibility of MR-guided radiotherapy to modify the stellate ganglia to achieve anatomical and functional sympathetic denervation.<br>This will be assessed according to the following outcome measures: <br>1.1.Physical modification of the stellate ganglia on MRI at baseline and at 6 months<br>1.2.Heart rate variability at baseline and at 6 months<br>1.3.Peripheral venous biomarker concentrations (Neuropeptide-Y, and catecholamines) at baseline and at 6 months.<br>1.4.The number of ventricular arrhythmias requiring device therapy 6 months before and after radiotherapy<br>1.5.Patient reported outcomes assessed with KCCQ-23 questionnaire at baseline and at 6 months.<br>2.Correlate the change in circulating biomarker levels with the efficacy of MR-guided radiotherapy to modify the stellate ganglia in terms of arrhythmic burden. This will be assessed through statistical correlation between changes in measured biomarker concentrations and changes in the number of ventricular arrhythmias.