Pilot study of New Generation Arrhythmia Treatment

JRCT ID: jRCTs032210505

Registered date:22/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atrial fibrillation
• Date of first enrollment: 22/12/2021
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Carbon-ion radiotherapy

Outcome(s)

Primary Outcome

Safety: acute (4 weeks post-irradiation) to late (48 weeks post-irradiation) myocardial damage*, pulmonary damage and esophageal mucosal damage
*Details of myocardial damage: decreased cardiac function (systolic and diastolic capacity), pericarditis, pericardial effusion, myocardial ischemia, heart failure, etc.
Efficacy: Effectiveness in reducing arrhythmias, stability assessment of depolarization, repolarization, and autonomic indices

• Secondary Outcome: Cardiac sympathetic denervation

Key inclusion & exclusion criteria

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

Include criteria

(1) Written consent for participation in this study has been obtained from the subject or a surrogate at the time consent is obtained.
(2) 18 years of age or older
3) The following patients with confirmed atrial fibrillation
i) Cancer patients
ii) Patients who are drug-refractory and eligible for catheter ablation, but difficult to perform because of the following reasons Patients who are physically too weak to undergo catheter ablation (PS1-3), have low ADL (Barthel Index 41-85), or are allergic to anesthesia.

Exclude criteria

1) Patients with a life expectancy of more than 12 months due to other diseases such as malignant tumors, or patients with poor general health (PS 4, or Barthel Index score of 40 or less)
2) Heart failure dependent on inotropic drugs or left ventricular assist device
3) Patients with organic heart disease requiring surgical treatment
4) Requires inpatient treatment for acute coronary syndrome or acute heart failure
5) High risk of radiation pneumonitis, such as idiopathic pulmonary fibrosis (IPF) evident on chest CT
(6) Undergoing maintenance hemodialysis or peritoneal dialysis
(7) The principal investigator judges that participation in this study is inappropriate due to reasons such as pregnancy or other illnesses that make it difficult to conduct necessary examinations or follow-up studies.

Related Information

• Primary Sponsor: Wakatsuki Masaru
• Secondary Sponsor: Amino Mari