Stereotactic Radiotherapy for Fatal Arrhythmias

JRCT ID: jRCTs042230030

Registered date:02/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ventricular tachycardia
• Date of first enrollment: 18/10/2023
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Stereotactic radiotherapy for VT origins

Outcome(s)

• Primary Outcome: Treatment safety in the early post-treatment period (within 1 year)
• Secondary Outcome: Treatment efficacy

Key inclusion & exclusion criteria

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

Include criteria

1) 18 years or older
2) After ICD implantation
3) Patients who have had a recurrence after more than 1 catheter ablation
4) Patients who have experienced 3 or more VT attacks within the past 3 months while taking at least 1 antiarrhythmic drug
5) Patients with fatal arrhythmia that cannot be cured by catheter ablation
6) Patients with no history of irradiation to the cardiac area
7) Patients with written consent from the patient

Exclude criteria

1) Heart failure dependent on left ventricular assist device
2) Patients with low probability of survival for more than 6 months due to factors other than VT
3) Cases in which irradiation is contraindicated
4) Patients undergoing maintenance hemodialysis or peritoneal dialysis
5) Patients with heart disease requiring surgical treatment
6) Patients with acute coronary syndrome or acute heart failure requiring hospitalization
7) Patient is at high risk of radiation pneumonitis, such as idiopathic pulmonary fibrosis (IPF) on chest CT
8) Difficult-to-control pericardial effusions or pleural effusions
9) Difficulty in maintaining supine rest for 1 hour.
10) Other illnesses or reasons that make it difficult to perform necessary examinations or follow-up investigations, or for which the principal investigator/participating physician determines that the patient is not suitable to participate in this study.

Related Information

• Primary Sponsor: Kawamura Mariko
• Source(s) of Monetary Support: Accuray Japan K.K.