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Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation - Comparison between Rivaroxaban and Warfarin -

Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation - Comparison between Rivaroxaban and Warfarin - - A Study on Anticoagulant Therapy in Catheter Ablation for Atrial Fibrillation - Rivaroxaban vs. Warfarin : A Comparative Study -

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013341
Enrollment
200
Registered
2014-03-05
Start date
2014-06-16
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

Non-valvular Atrial Fibrillation

Interventions

Rivaroxavan will be orally administered at a dose of 15 mg once daily after evening meal. The administration will start one month before ablation and last until one month after that. Warfarin will be

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who fulfill all of the following criteria 1. Be diagnosed non-valvular atrial fibrillation 2. Be scheduled for catheter ablation procedure for AF 3. Has a left atrial diameter <= 55 mm 4. Be aged from 20 to 80 years 5. Sign an informed consent document by himself/herself

Exclusion criteria

Exclusion criteria: Patients who fulfill at least one of the following criteria 1. Has a history of a prior stroke or TIA within 6 months before enrollment 2. Has a history of a major bleeding within 12 months before enrollment 3. Has had major surgery including CABG within 6 months before enrollment 4. Has a history of a MI within 2 months before catheter ablation procedure 5. Has a CrCl < 30 mL/min at screening 6. Has a diagnosis or clinical condition requiring use of dual anti-platelet therapy 7. Has contraindications of rivaroxaban or warfarin 8. Be a patient judged as "inappropriate" by an investigator

Design outcomes

Primary

MeasureTime frame
the incidence of asymptomatic cerebral infarction caused by catheter ablation

Secondary

MeasureTime frame
1. the occurrence of post-procedural (30-40 days) major bleeding event 2. the occurrence of post-procedural (30-40 days) thromboembolic event

Countries

Japan

Contacts

Public ContactSeiji Takatsuki

Keio University School of Medicine Department of Cardiology

seiji.takatsuki@gmail.com03-5843-6702

Outcome results

None listed

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