STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study

Sponsor
Nippon Medical School
Study ID
NCT03777631
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Catheter ablation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2018
Status verified
Nov 2023
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
251 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Standard medical therapy group
    The preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists.
  • Active Comparator: Catheter ablation group
    Catheter ablation (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. For conducting CA by a trained and experienced cardiologist, only institutions in which performed \>100 CA annually were participated in the present study in principle.

Primary Outcome Measure

Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. [ Time Frame: Up to 6 years ]

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