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Pilot study of New Generation Arrhythmia Treatment

Minimally Invasive Arrhythmia Therapy Using Carbon-Ion Beam Irradiation for Atrial Fibrillation in cancer patient

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210505
Enrollment
3
Registered
2021-12-22
Start date
2021-12-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation atrial fibrillation

Interventions

Hravy-ion particle therapy, particle therapy

Sponsors

Wakatsuki Masaru
Lead Sponsor
Amino Mari
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Cardiac sympathetic denervation

Contacts

Public ContactMasaru Wakatsuki

National Institute for Quantum Science and Technology

wakatsuki.masaru@qst.go.jp+81-43-206-3306

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026