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OCEAN

Optimal antiCoagulation for Enhanced risk pAtients Post-catheter ablatioN for atrial fibrillation trial

The number of patients recruited by Canberra Heart Rhythm: 34

Objective: is rivaroxaban superior to aspirin in prevention of stroke for patients post atrial fibrillation catheter ablation.

International multi-centre randomised open label study.

Primary endpoint:

Composite of stroke, systemic embolism and covert embolic stroke defined by cMRI

Inclusion Criteria

  • Patient must be at least one year post-successful catheter ablation(s) for atrial fibrillation without evidence of any clinically apparent arrhythmia recurrence defined as all of the following:
    No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent) from 2-6 months after the last ablation, AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after 6 months after the last ablation AND no AF/AT/AFL on at least 24 hour Holter and ECG 2 months before enrolment in the study. The Holter/ECG within 2 months of enrolment may also serve as the Holter performed 6 months or later after the last ablation
  • Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients in whom female sex or vascular disease are their sole risk factor may not be enrolled.
  • Patient must be >18 years of age.
  • Patient must have non-valvular AF.

Exclusion Criteria

  • Bleeding contra-indication to oral anticoagulation, or medications with strong interactions with oral anticoagulation
  • Non-arrhythmic condition necessitating long-term oral anticoagulation.
  • Contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
  • Contraindication to implantation of an implantable loop recorder (such as limited immunocompetence or a wound healing disorder).
  • Valvular atrial fibrillation
  • Severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
  • Special risk factors for stroke unrelated to AF, specifically known thrombophilia/hypercoagulability, uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
  • > 85 years of age.
  • Critically ill or who have a life expectancy <3 years.
  • Once enrolled, randomisation into either:
    • Rivaroxaban 15mg daily
    • Aspirin 75-160mg daily
  • MRI at baseline and 3 year follow up
  • Subset of patients (n=500) will have implantable loop recorder inserted