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The Prospective Randomized Controlled Trial Evaluating Efficacy of Saireito for Early Rcurrence after Catheter Ablation for Atrial Fibrillation

SAIreito Reduces Early recurrence after Intervention for aTrial fibrillation, Or not study - SAIREITO study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039190
Enrollment
100
Registered
2020-07-01
Start date
2020-08-01
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

Interventions

Intake of saireito for 1 month after ablation procedure Control (No Saireito)

Sponsors

Department of Cardiovascular Medicine,Kyoto University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing first catheter ablation including PV isolation for symptomatic atrial fibrillation Patients who are 21-85 years old Able to be followed for one year in an out-patient clinic Willing to sign the consent form for participation

Exclusion criteria

Exclusion criteria: Patients who previously received ablation procedure surgical MAZE procedure for AF Contraindication or intolerance to Saireito, including severe interstitial pneumonitis, and aldosteronism Patients who already take Saireto at the time of procedure Renal insufficiency (estimated Glomerular Filtration Rate <30 or hemodialysis) Patients who received immunosuppressants (PSL or infliximab, etc) Liver insufficiency When the attending physician consider inappropriate to enroll the patient in the study Unwilling to sign the consent form for participation

Design outcomes

Primary

MeasureTime frame
Early recurrence (atrial arrhythmia recurrence within 90 days) after catheter ablation for atrial fibrillation—

Secondary

MeasureTime frame
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—

Countries

Japan

Contacts

Public ContactTetsuma Kawaji

Mitsubishi Kyoto Hospital Department of Cardiology

kawaji@kuhp.kyoto-u.ac.jp075(381)2111

Outcome results

None listed

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