Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral
anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)

Objective:

- To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse
clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction
(MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major
bleeding (International Society on Thrombosis and Haemostasis [ISTH] definition).

- To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).

Criteria : Inclusion Criteria:

- Meets protocol-specified criteria for qualification and contraception

- Is willing and able to comply with any restrictions related food, drink and
medications

- Voluntarily consents to participate and provides written informed consent prior to any
protocol-specific procedures

Exclusion Criteria:

- Has history or current use of over-the-counter medications, dietary supplements, or
drugs (including nicotine and alcohol) outside protocol-specified parameters

- Has signs, symptoms or history of any condition that, per protocol or in the opinion
of the investigator, might compromise:

1. the safety or well-being of the participant or study staff

2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding)

3. the analysis of results