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

JRCT ID: jRCTs031180249

Registered date:12/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-valvular atrial fibrillation
• Date of first enrollment: 28/03/2018
• Target sample size: 250
• Study type: Interventional

Intervention(s)

Standard medication group:
The preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists.

Catheter ablation additional group:
Catheter ablation should be performed from the onset of ischemic stroke. Catheter ablation is based on pulmonary vein isolation, with atrial ablation as required.

Outcome(s)

Primary Outcome

The following composite events during observation period
1) Recurrence of ischemic stroke
2) Systemic embolism
3) All-cause death
4) Hospitalization for heart failure

Secondary Outcome

<<Secondary Endpoints>>
1)Onset of stroke
2)Recurrence of ischemic stroke
3)Systemic embolism
4)All-cause death
5)Cardiovascular death
6)Hospitalization for heart failure
7)Any bleeding
8)Onset of intracranial hemorrhage
9)Composite events (all-cause death, onset of stroke, systemic embolism, hospitalization for heart failure, and serious adverse event caused by catheter ablation)

<<Other Endpoints>>
1)Modified Rankin scale score and NYHA classification at the end of observation period
2)Maintenance rate of sinus rhythm
3)Changes in Mini-Mental State Examination (MMSE) scores during observation period
4)The continuation rate of edoxaban
5)Recurrence rate of stroke according to whether or not Edoxaban discontinue
6)Factors which contribute to discontinue edoxaban

<<Safety outcomes>>
1)Serious adverse events related to catheter ablation maneuver
2)All adverse events not related to catheter ablation maneuver
3)Drug reaction to edoxaban

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kimura Kazumi
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd.
• Secondary ID(s): UMIN000031424