STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillatio

Phase 4

• Conditions: on-valvular atrial fibrillation

• Registration Number: JPRN-jRCTs031180249
• Lead Sponsor: Kimura Kazumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1)Age >=20 and =<85 years at time of giving informed consent
2)Nonvalvular atrial fibrillation
3)History of ischemic stroke in previous 6 months
4)Current or planned treatment with edoxaban
5)Modified Rankin Scale (mRS) =<3

Exclusion Criteria

1)Symptomatic paroxysmal atrial fibrillation resistant to anti-arrhythmic drugs
2)Presence of left atrial thrombus and/or left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
3)Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy
4)Presence of severe renal disorder(estimated creatinine clearance <30 mL/min by Cockroft-Gault equation)
5)Previous catheter ablation or surgical intervention for atrial fibrillation
6)History of treatment with a left atrial appendage closure device
7)Left atrial diameter >=55 mm on transthoracic echocardiography
8)Ejection fraction =<35% on transthoracic echocardiography
9)Persistent Sustained AF for >=10 years
10)Atrial septal defect (ASD)
11)Pregnant or possibility of pregnancy
12)Unlikely to complete the study, such as due to progressive malignant tumor
13)Participating or planning to participate in another interventional clinical trial
14)Unwilling to participate
15)Judged as incompatible for the study by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified