Prospective Study regarding the Safety of a Periprocedual Anticoagulation Regimen with Direct Oral Anticoagulant (DOAC) Other than Dabigatran in the Patients Undergoing Catheter Ablation for Paroxysmal or Persistent Atrial Fibrillation.

Not Applicable

• Conditions: paroxysmal or persistent atrial fibrillation

• Registration Number: JPRN-UMIN000028892
• Lead Sponsor: Shonankamakura General Hospital Department of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-07
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with a history of hypersensitivity to components of Prazaxa capsules 2) Patients with hemorrhagic symptoms, patients with hemorrhagic diathesis and patients with hemostatic disorder 3) Patients with COPD and severe respiratory disease 4) Patients with advanced renal injury including dialysis patients (creatinine clearance less than 30 mL / min) 5) Patients with severe liver disease (AST (GOT) or ALT (GPT)> 100 U) 6) Women who may be pregnant or have a possibility of pregnancy 7) Women who are breastfeeding 8) Patients who are diagnosed as having a life expectancy of less than half a year 9) Patients who received other test drugs or investigational drugs within 3 months before the start of administration of study drug 10) Patients with organic lesions at risk of clinically serious bleeding (including hemorrhagic stroke within 6 months) 11) Patients who have indwelling spinal and epidural catheters and patients within 1 hour after removal 12) Patients receiving itraconazole (oral preparation) 13) Patients with cryoglobulinemia 14) In addition, patients who are deemed inappropriate as research subjects by research managers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of major bleeding events which is defined by ISTH(International Society of Thrombosis and Hemostasis) during and up to 12 weeks after ablation

Secondary Outcome Measures

Name	Time	Method
Following events during and up to 12 weeks after ablation ; thromboembolic events (stroke, systemic embolism) ; Minor bleeding events which were defined as clinical bleeding events that did not fulfill ISTH criteria for major bleeding events. ; a composite of major bleeding events and thromboembolic events (stroke, systemic embolism).