The Prospective Randomized Controlled Trial Evaluating Efficacy of Saireito for Early Rcurrence after Catheter Ablation for Atrial Fibrillatio
Not Applicable
- Conditions
- Atrial fibrillation
- Registration Number
- JPRN-UMIN000039190
- Lead Sponsor
- Department of Cardiovascular Medicine,Kyoto University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early recurrence (atrial arrhythmia recurrence within 90 days) after catheter ablation for atrial fibrillation
- Secondary Outcome Measures
Name Time Method 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