STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular At… (NCT03777631) | Clinical Trial Compass
UnknownPhase 3
STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
Japan251 participantsStarted 2018-04-01
Plain-language summary
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.
Who can participate
Age range20 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥20 or ≤85 years at time of giving informed consent
* Nonvalvular atrial fibrillation
* History of stroke in previous 6 months
* Current or planned treatment with edoxaban
* Modified Rankin scale ≤3
Exclusion Criteria:
* Symptomatic paroxysmal AF resistant to anti-arrhythmic drugs
* Presence of left atrial thrombus and left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
* Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy.
* Presence of severe renal disorder (estimated creatinine clearance \<30 mL/min by Cockroft-Gault equation)
* Previous CA or surgical intervention for AF
* History of treatment with a left atrial appendage closure device
* Left atrial diameter ≥55 mm on transthoracic echocardiography
* Ejection fraction ≤35% on transthoracic echocardiography
* Persistent AF for ≥10 years
* Pregnant or possibility of pregnancy
* Unlikely to complete the study, such as due to progressive malignant tumor
* Participating or planning to participate in another clinical trial
* Unwilling to participates
* Judged as incompatible for the study by the investigators
What they're measuring
1
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.