Stereotactic Radio-regulation Antiarrhythmic Therapy trial

JRCT ID: jRCTs032190041

Registered date:19/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intractable Ventricular Arrhythmia
• Date of first enrollment: 25/09/2019
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Arrhythmia treatment by external radiation using X-ray or carbon-ion-beam equipment for cancer treatment

Outcome(s)

Primary Outcome

1) Safety: acute to late myocardium damage *, presence or absence of lung damage
* myocardium damage: Cardiac dysfunction (systolic ability, diastolic ability), pericarditis, pericardial effusion, myocardial ischemia, heart failure etc.
2) Efficacy: Arrhythmic reduction effect, evaluation of stability of depolarization, repolarization and autonomic nerve index

• Secondary Outcome: Cardiac sympathetic denervation effect

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Eligible patients had more than 3 episodes of sustained monomorphic VT or cardiomyopathy* (left ventricular ejection fraction less than 50%) related to monomorphic premature ventricular contractions (PVCs beyond 20%) and required failure of more than 1 antiarrhythmic medication and more than 1 catheter ablation (or had a contraindication to catheter ablation such as anatomical difficulty or epicardial origin, or patient's rejection**). Patients could not have received past radiotherapy to the anticipated treatment field.
*Cardiomyopathy can be ischemic or non-ischemic (idiopathic, contractile pericarditis, valvular disease, etc.)
**Even if two independent cardiologists give enough explanation, it is assumed that the patient's informed consent was not obtained.

Exclude criteria

Patients were deemed ineligible if they had heart failure dependent on inotropes or a left-ventricular assist device or were deemed unlikely to live 12 months in the absence of VT. Patients were also ineligible if they had polymorphic VT or ventricular fibrillation, beyond 3 distinct clinical VT morphologies, or beyond 5 induced VT morphologies during noninvasive-programmed stimulation testing by using ICD.

Even if the above selection criteria and exclusion criteria are met, patients who fall under any of the following conditions are excluded
1. Maintenance hemodialysis or peritoneal dialysis is performed.
2. Organic heart disease requiring surgical treatment.
3. Hospitalization is required for acute coronary syndrome or acute heart failure.
4. High risk of radiation pneumonitis, eg evidence of idiopathic pulmonary fibrosis on chest CT.
5. The research investigator or associate physician judges that participation in this study is inappropriate. For example, it may be considered difficult to carry out necessary tests and follow-up due to other diseases or reasons.

Related Information

• Primary Sponsor: Yoshioka Koichiro