To evaluate a new implantable device, the Watchman FLX in patients with non-valvular atrial fibrillation who have an increased stroke risk.
To be considered for the study you must meet the following criteria:
- 18 years of age or older
- Have a calculated CHA2DS2-VASc score of ≥2 for males or ≥3 for females
- Undergone a prior catheter ablation procedure for non-valvular atrial fibrillation between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).
Your participation in this study would be for approximately 3 years.
You will need to attend the clinic for an initial assessment, including medical and medication history, physical examination, blood tests, echocardiogram and completing questionnaires regarding quality of life.
You will then be randomized 1:1 to receive either the device implantation or oral anticoagulants. You will be followed up in clinic at 3, 12, 24 and 36 months, where you will again be asked about your health and medications, have a physical examination and asked to complete questionnaires about your quality of life. For participants randomised to an implantable device, a transoesophageal echo will also be performed at 3 and 12 months
You will be reimbursed for any study-related travel and expenses.