OCEAN

Is Stroke Risk Abated Once You Are Ablated?

The OCEAN trial will compare medical approaches for stroke prevention in people who have atrial fibrillation (AF) but have undergone a successful ablation to eliminate or substantially reduce the arrhythmia. AF is normally associated with an increased risk of stroke; this risk can be reduced using treatment with oral anticoagulants. However, it is unknown if elimination or substantial reduction of AF with an ablation procedure also reduces the risk of stroke associated with AF. If it does reduce the stroke risk, then patients who have a successful ablation may not need to continue on life-long oral anticoagulant therapy. However, this benefit has to be weighed against the risk of ongoing stroke despite significant AF reduction. This trial will compare a strategy of oral anticoagulant therapy with rivaroxaban to an aspirin a day after successful AF ablation. The primary outcome will be a composite of stroke, systemic embolism and silent cerebral infarction as defined by cerebral magnetic resonance imaging. A pre-specified subset of patients will also undergo insertion of an implantable loop recorder capable of automated AF detection. Over 1500 patients will be enrolled overall.

OCEAN – ClinicalTrials.gov

Principal Investigators

Countries Participating

• Australia
• Belgium
• Canada
• China
• Germany
• Israel