Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucidated in NVAF with recent cerebral infarction in prospective randomized trials.
In patients with NVAF, stroke is an independent risk factor for a subsequent cerebral infarction. Although anticoagulant therapy can effectively reduce thromboembolic events, the reported annual recurrence rate in NVAF and previous stroke patients in the "real-world" is not low even with appropriate antithrombotic treatment; 8.6% in patients with "guideline adherent" antithrombotic therapy and around 5% in patients treated with anticoagulant therapy. NVAF and recent stroke is high-risk population for stroke recurrence even with anticoagulant therapy, and developing optimal secondary prevention strategy is an urgent task. Catheter ablation (CA) is now widely used to treat symptoms related to NVAF. Some retrospective studies showed a beneficial effect of CA for stroke prevention using age-/sex-matching or propensity-score matching. Moreover, CA have a potential to improve survival or prevent heart failure development in patients with AF. However, the effect of CA for secondary stroke prevention or impact of CA for NVAF patients with recent ischemic stroke for survival or developing heart failure has not been evaluated in a prospective randomized trial. Therefore, in the present study, we intend to compare two groups of patients with NVAF with a history of cerebral infarction: a group receiving standard medical therapy (control group) and a group receiving standard medical therapy plus CA (CA group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
251
CA should be performed within 1-6 months from the onset of cerebral infarction. CA is based on pulmonary vein isolation, with atrial ablation as required.
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
Time frame: Up to 6 years
Recurrence of cerebral infarction
Recurrence of cerebral infarction
Time frame: Up to 6 years
Systemic embolism
Symptomatic systemic embolism to other regions than brain, e.g. peripheral or visceral arteries
Time frame: Up to 6 years
All-cause death
All-cause death
Time frame: Up to 6 years
Cardiovascular death
Cardiovascular death
Time frame: Up to 6 years
Hospitalization for heart failure
Hospitalization for heart failure
Time frame: Up to 6 years
Any bleeding
Any bleeding
Time frame: Up to 6 years
Intracranial hemorrhage
Intracranial hemorrhage
Time frame: Up to 6 years
Composite events
all-cause death, onset of stroke, systemic embolism, hospitalization for heart failure, and serious adverse event caused by CA
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Time frame: Up to 6 years
The rate of and related factors to discontinuation of Edoxaban
The rate of and related factors to discontinuation of Edoxaban
Time frame: Up to 6 years
Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban
Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban
Time frame: Up to 6 years