Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation - In Atrial Fibrillation

Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation - In Atrial Fibrillation - ENVISAGE-TAVI AF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031927

Enrollment

1400

Registered

2018-03-27

Start date

2018-05-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Interventions

Edoxaban-based regimen (up to 3 years) VKA (Vitamin K antagonist)-based regimen (up to 3 years)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Successful transcatheter aortic valve implantation (TAVI) 2. Indication for chronic OAC 3. Provision of signed informed consent

Exclusion criteria

Exclusion criteria: 1. Conditions with a high risk of bleeding 2. Serious unresolved periprocedural complications 3. Any contraindication to both Edoxaban and VKA per local label 4. Clinically overt stroke within the last 90 days before TAVI

Design outcomes

Primary

Measure	Time frame
- NACE, i.e., the composite of all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding (ISTH definition) - Major bleeding (ISTH definition)	—

Countries

Japan,Asia(except Japan),North America,Europe

Contacts

Public ContactYoshitaka Kurokane

Labcorp Development Japan K.K. Clinical Operations

yoshitaka.kurokane@labcorp.com+81-3-6837-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026