Saireito in Catheter Ablation for Atrial Fibrillation

JRCT ID: jRCTs051200037

Registered date:30/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 05/08/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Intake of saireito for 1 month after ablation procedure

Outcome(s)

• Primary Outcome: Early recurrence (atrial arrhythmia recurrence within 90 days) after catheter ablation for atrial fibrillation

Secondary Outcome

Adverse events within 30 days after procedure
QOL score at 30-day
Change of cardiac, inflammation, renal biomarker (TnI,CRP,NGAL)
Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

First time ablation procedure for symptomatic atrial fibrillation
Patients who can be followed for 1-year after procedure
Patients from who we get written informed consent

Exclude criteria

Severe complications of ablation procedure
Patients who received ablation procedure or MAZE procedure for for atrial fibrillation before enrollment
Patients who already take Saireito
Chronic kidney disease (eGFR<30 or hemodialysis)
Chronic liver failure
Patients who can not take Saireito

Related Information

• Primary Sponsor: Shizuta Satoshi
• Secondary Sponsor: Operation Cost Grant
• Secondary ID(s): UMIN000039190