Refractory Cardiac Ventricular Arrhythmias Refractory Cardiac Ventricular Arrhythmias
Conditions
Interventions
Arrhythmia treatment by external radiotherapy system
Sponsors
Shoda Morio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Ventricular tachycardia or ventricular fibrillation (regardless of waveform, duration, or type) 3 times in the past 3 months have experienced more than one episode (2)Cardiomyopathy* (EF<50%) caused by premature ventricular contractions Any of the above diseases that meet the following conditions: -Cases with resistance to at least one antiarrhythmic drug or difficulty in taking oral medication or -History of one or more catheter ablations, ineligible cases (anatomical difficulties, epicardial origin), or patient refusal** *Cardiomyopathy can be ischemic or non-ischemic (idiopathic, constrictive pericarditis, valvular disease, etc.) **If consent is not obtained even after sufficient explanations have been provided by two independent cardiologists using the prescribed explanatory documents, the content and date and time of the explanations will be recorded on the medical record.
Exclusion criteria
Exclusion criteria: (1) Heart failure dependent on inotropes (2) Cases unlikely to live 12 months due to factors other than VT (3)History of radiation to the heart area Furthermore, patients who meet the above selection criteria, do not violate the exclusion criteria, and meet any of the following conditions will be excluded: 1) Have organic heart disease requiring surgical treatment 2) Requires hospitalization for acute coronary syndrome or acute heart failure 3) High risk of radiation pneumonitis, such as evidence of idiopathic pulmonary fibrosis (IPF) on chest CT 4) The clinical trial investigator or clinical research subinvestigator deems it inappropriate to participate in this study, such as due to other diseases or reasons that make necessary tests or follow-up surveys difficult.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Safety: Presence of acute to late myocardial damage-1 and lung damage -1:Details of myocardial damage: decreased cardiac function (systolic and diastolic capacity), pericarditis, pericardial effusion, myocardial ischemia, heart failure, etc. The primary safety endpoint will be 90 days after the start of treatment. (2) Efficacy: Arrhythmia reduction effect (recurrence rate, ICD activation rate) and life prognosis The primary efficacy endpoint will be 6 months after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Cardiac sympathetic nerve denervation effect (2) Stability evaluation of depolarization/repolarization/autonomic nerve indicators, progression-free period | — |
Contacts
Public ContactDaigo Yagishita
Tokyo Women's Medical University Hospital
Outcome results
None listed